https://reguvirta.com/posts/Reporting_Requirements_and_Testing_Standards_for_Cabinet_X-ray_Systems/ 1975-02-01T12:00:00-05:00 https://reguvirta.com/posts/Classification_of_Electron_Beam_Accelerators_Used_as_Laser_Energy_Sources/ 1975-11-21T12:00:00-05:00 https://reguvirta.com/posts/Viewing_Optics_Performance_Requirements_for_Surveying_Laser_Products/ 1976-08-05T12:00:00-04:00 https://reguvirta.com/posts/Remote_Interlock_Connector_Requirements_for_Laser_Products/ 1976-10-07T12:00:00-04:00 https://reguvirta.com/posts/Laser_Products_Sold_in_Kit_Form__Identification,_Certification_and_Compliance_Requirements/ 1976-10-14T12:00:00-04:00 https://reguvirta.com/posts/In-House_Manufactured_Laser_Products__Applicability_of_Federal_Performance_Standards/ 1976-11-23T12:00:00-05:00 https://reguvirta.com/posts/Emergency_Use_Oxygen_Generators_and_Oxygen_Equipment__Flow_Rate_and_Distribution_Requirements/ 1977-01-01T12:00:00-05:00 https://reguvirta.com/posts/Warning_Label_Requirements_for_Multiple_Wavelength_and_Dye_Laser_Products/ 1977-03-02T12:00:00-05:00 https://reguvirta.com/posts/Laser_Light_Shows_and_Demonstration_Laser_Products__Performance_Standards_and_Manufacturer_Requirements/ 1977-11-23T12:00:00-05:00 https://reguvirta.com/posts/Clinical_and_Non-Clinical_Testing_Requirements_for_Hysteroscopic_Sterilization_Devices/ 1978-05-09T12:00:00-04:00 https://reguvirta.com/posts/Good_Laboratory_Practice_(GLP)_Requirements_for_Non-Clinical_Laboratory_Studies/ 1979-08-31T12:00:00-04:00 https://reguvirta.com/posts/Quality_Control_Practices_for_Mercury_Vapor_Lamp_Manufacturing_and_Testing/ 1980-05-01T12:00:00-04:00 https://reguvirta.com/posts/Alternative_Warning_Statements_for_Laser_Product_User_Information/ 1980-08-25T12:00:00-04:00 https://reguvirta.com/posts/X-ray_Field_Size_Control_Requirements_for_Fluoroscopic_and_Spot-Film_Systems/ 1980-09-30T12:00:00-04:00 https://reguvirta.com/posts/Significant_Risk_Determination_for_Investigational_Medical_Laser_Devices/ 1981-05-18T12:00:00-04:00 https://reguvirta.com/posts/Exemptions_from_Reporting_Requirements_for_Limited_Production_of_Sunlamp_Products_for_Commercial_Use/ 1981-09-16T12:00:00-04:00 https://reguvirta.com/posts/Safety_Requirements_for_Medical_Laser_Delivery_Systems_and_Interlock_Mechanisms/ 1985-01-20T12:00:00-05:00 https://reguvirta.com/posts/Reproduction_of_Hazard_Warning_Labels_in_User_Instructions_for_Laser_Products_with_Cosmetic_Enclosures/ 1985-02-05T12:00:00-05:00 https://reguvirta.com/posts/Classification_of_Large_Laser-Based_Materials_Processing_Machines_with_Walk-In_Workstations/ 1985-10-21T12:00:00-04:00 https://reguvirta.com/posts/Compatibility_Criteria_for_Replacement_UV_Lamps_in_Sunlamp_Products/ 1986-09-02T12:00:00-04:00 https://reguvirta.com/posts/Color_Additives_in_Medical_Devices__Requirements_for_Direct_Body_Contact_Applications/ 1987-06-01T12:00:00-04:00 https://reguvirta.com/posts/Device_Master_Files_-_Content,_Format,_and_Submission_Requirements/ 1987-06-01T12:00:00-04:00 https://reguvirta.com/posts/Calibration_Constancy_Intercomparison_System_for_Microwave_Oven_Survey_Instruments/ 1988-03-01T12:00:00-05:00 https://reguvirta.com/posts/Quality_Control_and_Quality_Assurance_for_Sunlamp_Products_and_UV_Lamps/ 1988-03-01T12:00:00-05:00 https://reguvirta.com/posts/Requirements_for_510k_Submissions_for_Oxygen_Conserving_Devices/ 1989-02-01T12:00:00-05:00 https://reguvirta.com/posts/Radiation_Safety_Requirements_for_Diagnostic_X-Ray_Systems_and_Components/ 1989-02-28T12:00:00-05:00 https://reguvirta.com/posts/Diagnostic_X-Ray_Systems__Component_Labeling,_Assembly,_and_Safety_Requirements/ 1989-03-01T12:00:00-05:00 https://reguvirta.com/posts/Radiation_Control_Requirements_and_Interpretations_for_Diagnostic_X-ray_Equipment/ 1989-03-01T12:00:00-05:00 https://reguvirta.com/posts/Reinspection_of_Firms_During_Pending_Legal_Actions/ 1989-08-30T12:00:00-04:00 https://reguvirta.com/posts/Labeling_Requirements_and_Recommendations_for_Medical_Devices/ 1989-09-01T12:00:00-04:00 https://reguvirta.com/posts/Quality_Assurance_Guidelines_for_Hemodialysis_Devices_and_Facilities/ 1991-02-01T12:00:00-05:00 https://reguvirta.com/posts/Device_Labeling_Requirements_and_Content_for_Premarket_Approval_Applications/ 1991-03-07T12:00:00-05:00 https://reguvirta.com/posts/Shelf_Life_and_Stability_Testing_for_Medical_Devices/ 1991-04-01T12:00:00-05:00 https://reguvirta.com/posts/In_Vitro_Diagnostic_Devices_for_Detection_of_Parvovirus_B19_Antibodies_in_Human_Serum_and_Plasma/ 1992-05-15T12:00:00-04:00 https://reguvirta.com/posts/Laser_Products_-_Performance_Standards_and_Safety_Requirements/ 1992-06-01T12:00:00-04:00 https://reguvirta.com/posts/Premarket_Notification_Requirements_for_Gastroenterology_and_Urology_Biopsy_Devices/ 1993-02-09T12:00:00-05:00 https://reguvirta.com/posts/Ureteral_Stents_-_Content_and_Testing_Requirements_for_510k_Submissions/ 1993-02-09T12:00:00-05:00 https://reguvirta.com/posts/Clinical_Electronic_Thermometers_-_Review_Requirements_and_Testing_Specifications/ 1993-02-28T12:00:00-05:00 https://reguvirta.com/posts/Premarket_Notification_Requirements_for_Healthcare_Facility_Sterilizers/ 1993-03-01T12:00:00-05:00 https://reguvirta.com/posts/510k_Requirements_for_Hypodermic_Single_Lumen_Needles/ 1993-03-31T12:00:00-05:00 https://reguvirta.com/posts/Piston_Syringes_and_Accessories_-_Review_Requirements_and_Testing_Specifications_for_510k_Submissions/ 1993-03-31T12:00:00-05:00 https://reguvirta.com/posts/Electromagnetic_Compatibility_Testing_and_Safety_Requirements_for_Powered_Wheelchairs/ 1993-05-10T12:00:00-04:00 https://reguvirta.com/posts/Beam_Attenuator_and_Emission_Indicator_Requirements_for_Class_II_and_IIIa_Visible_Laser_Systems/ 1993-06-07T12:00:00-04:00 https://reguvirta.com/posts/Endoscope_Washers_and_Washer_Disinfectors_-_510k_Review_Requirements/ 1993-08-01T12:00:00-04:00 https://reguvirta.com/posts/Surgical_Gowns_and_Surgical_Drapes_-_Performance_Testing_and_Labeling_Requirements/ 1993-08-01T12:00:00-04:00 https://reguvirta.com/posts/Premarket_Notification_Requirements_for_Aerosol_Delivery_Devices__Nebulizers,_Metered_Dose_Inhalers,_Spacers_and_Actuators/ 1993-09-30T12:00:00-04:00 https://reguvirta.com/posts/Medical_Waste_Sharps_Containers_and_Secondary_Sharps_Containers_-_Design,_Testing,_and_Labeling_Requirements/ 1993-10-01T12:00:00-04:00 https://reguvirta.com/posts/Enforcement_Policy_for_Positive-Beam_Limitation_Requirements_in_Diagnostic_X-Ray_Systems/ 1993-10-13T12:00:00-04:00 https://reguvirta.com/posts/Regulatory_Requirements_for_Condom-Like_Products_and_Novelty_Condoms/ 1994-02-23T12:00:00-05:00 https://reguvirta.com/posts/Testing_Requirements_for_Orthopedic_Implants_with_Modified_Metallic_Bone-Interface_Surfaces/ 1994-04-27T12:00:00-04:00 https://reguvirta.com/posts/Premarket_Notification_Requirements_for_Urine_Drainage_Bags_and_Accessories/ 1994-06-07T12:00:00-04:00 https://reguvirta.com/posts/Cervical_Cytology_Device_Development_and_Validation_Requirements/ 1994-07-25T12:00:00-04:00 https://reguvirta.com/posts/Extended_Laparoscopy_Devices_-_Premarket_Notification_(510k)_Submissions/ 1994-08-29T12:00:00-04:00 https://reguvirta.com/posts/Premarket_Notification_Requirements_for_Conventional_and_Antimicrobial_Foley_Catheters_with_Balloon_Retention/ 1994-09-11T12:00:00-04:00 https://reguvirta.com/posts/Premarket_Notification_Requirements_for_Sterile_Lubricating_Jelly_Used_with_Transurethral_Surgical_Instruments/ 1994-09-18T12:00:00-04:00 https://reguvirta.com/posts/510k_Submissions_for_Mechanical_Lithotripters_and_Stone_Dislodgers_in_Gastroenterology_and_Urology/ 1994-11-01T12:00:00-05:00 https://reguvirta.com/posts/Ceramic_Ball_Hip_Systems_-_Requirements_for_510k_Premarket_Notifications/ 1995-01-09T12:00:00-05:00 https://reguvirta.com/posts/Applicability_of_Sunlamp_Performance_Standards_to_UVA_Tanning_Products_(Revoked)/ 1995-02-28T12:00:00-05:00 https://reguvirta.com/posts/Correction_and_Reporting_Requirements_for_Diagnostic_X-Ray_Equipment_Defects_and_Noncompliances/ 1995-02-28T12:00:00-05:00 https://reguvirta.com/posts/Model_and_Serial_Number_Labeling_Requirements_for_X-Ray_System_Components/ 1995-02-28T12:00:00-05:00 https://reguvirta.com/posts/Recordkeeping_Requirements_and_Exemptions_for_Portable_Home_Sunlamp_Products_and_UV_Lamps/ 1995-02-28T12:00:00-05:00 https://reguvirta.com/posts/Enforcement_Policy_for_X-Ray_Assembly_Report_Filing_Requirements/ 1995-03-01T12:00:00-05:00 https://reguvirta.com/posts/Testing_of_Non-Articulating,_Mechanically_Locked_Modular_Implant_Components_in_Orthopedic_Devices/ 1995-04-30T12:00:00-04:00 https://reguvirta.com/posts/Content_and_Format_Requirements_for_Medical_Laser_510k_Submissions/ 1995-05-31T12:00:00-04:00 https://reguvirta.com/posts/Testing_and_Labeling_Requirements_for_Non-Latex_Male_Condoms/ 1995-06-28T12:00:00-04:00 https://reguvirta.com/posts/Premarket_Notification_Requirements_for_Manual_and_Powered_Wheelchairs_and_Three-Wheeled_Vehicles/ 1995-07-25T12:00:00-04:00 https://reguvirta.com/posts/Preparing_510k_Submissions_for_Heating_and_Cooling_Therapeutic_Devices/ 1995-07-25T12:00:00-04:00 https://reguvirta.com/posts/Preparing_510k_Submissions_for_Medical_Exercise_Equipment/ 1995-07-25T12:00:00-04:00 https://reguvirta.com/posts/Premarket_Notification_Requirements_for_Hysteroscopic_and_Laparoscopic_Insufflators/ 1995-07-31T12:00:00-04:00 https://reguvirta.com/posts/User_Instructions_for_Medical_Laser_Products__Safety_Information_and_Radiation_Hazard_Protection_Requirements/ 1995-08-11T12:00:00-04:00 https://reguvirta.com/posts/Testing_Requirements_for_Healthcare_Facility_Sterilizers_with_Non-Traditional_Cycle_Parameters/ 1995-09-18T12:00:00-04:00 https://reguvirta.com/posts/Premarket_Notification_Requirements_for_Hysteroscopes_and_Gynecologic_Laparoscopes/ 1996-03-07T12:00:00-05:00 https://reguvirta.com/posts/IDE_Requirements_for_Thermal_Endometrial_Ablation_Devices/ 1996-03-13T12:00:00-05:00 https://reguvirta.com/posts/Medical_Device_Reporting_Requirements_for_User_Facilities/ 1996-04-01T12:00:00-05:00 https://reguvirta.com/posts/Format_and_Content_of_IDE_Progress_Reports/ 1996-05-31T12:00:00-04:00 https://reguvirta.com/posts/Laser_Light_Shows_and_Displays__Requirements_for_Aircraft_Safety_and_Visual_Control/ 1996-06-06T12:00:00-04:00 https://reguvirta.com/posts/Medical_Device_Reporting__Manufacturer_Report_Number_Format_Variances/ 1996-07-15T12:00:00-04:00 https://reguvirta.com/posts/Use_of_Reporting_Site_Registration_Number_for_Medical_Device_Reports_(MDR)_Instead_of_Manufacturing_Site_Number/ 1996-08-11T12:00:00-04:00 https://reguvirta.com/posts/Alternative_Identification_Labeling_Requirements_for_Class_I_Laser_Products_Integrated_into_Other_Products/ 1996-09-05T12:00:00-04:00 https://reguvirta.com/posts/Use_of_Visible_Laser_Beam_as_Emission_Indicator_for_Class_II_and_Class_IIIa_Laser_Products/ 1996-09-05T12:00:00-04:00 https://reguvirta.com/posts/Investigational_Device_Exemptions_(IDE)_Requirements_for_Refractive_Surgery_Excimer_Lasers/ 1996-10-09T12:00:00-04:00 https://reguvirta.com/posts/Barrier_Devices_for_STD_Protection_During_Oral_Sex_-_Requirements_for_510k_Submissions/ 1996-10-30T12:00:00-05:00 https://reguvirta.com/posts/Export_Requirements_for_Products_Not_Approved_for_Sale_in_the_United_States/ 1996-12-01T12:00:00-05:00 https://reguvirta.com/posts/Review_Criteria_for_Vitreous_Aspiration_and_Cutting_Devices/ 1997-01-30T12:00:00-05:00 https://reguvirta.com/posts/Review_Criteria_for_Phacofragmentation_Systems_Used_in_Cataract_Surgery/ 1997-01-31T12:00:00-05:00 https://reguvirta.com/posts/Hydroxyapatite_Coated_Orthopedic_Implants_-_Information_for_510k_Submissions/ 1997-02-19T12:00:00-05:00 https://reguvirta.com/posts/Checklist_for_Orthopedic_External_Fixation_Device_Submissions/ 1997-02-20T12:00:00-05:00 https://reguvirta.com/posts/Non-Invasive_Blood_Pressure_Monitoring_Devices_-_Testing_and_Documentation_Requirements_for_510k_Submissions/ 1997-03-09T12:00:00-05:00 https://reguvirta.com/posts/Design_Controls_for_Medical_Device_Manufacturers/ 1997-03-11T12:00:00-05:00 https://reguvirta.com/posts/Medical_Device_Convenience_Kits_-_Premarket_Notification_and_Compliance_Requirements/ 1997-05-19T12:00:00-04:00 https://reguvirta.com/posts/Medical_Device_Kit_Component_Certification_Requirements_for_510k_Submissions/ 1997-06-30T12:00:00-04:00 https://reguvirta.com/posts/Maintaining_Independence_of_Industry-Supported_Scientific_and_Educational_Activities/ 1997-11-01T12:00:00-05:00 https://reguvirta.com/posts/Direct_Final_Rulemaking_Procedures_and_Implementation_Process/ 1997-11-20T12:00:00-05:00 https://reguvirta.com/posts/Industry-Supported_Scientific_and_Educational_Activities__Maintaining_Independence_from_Promotional_Influence/ 1997-12-03T12:00:00-05:00 https://reguvirta.com/posts/Class_II_Device_510k_Exemption_Process_and_Evaluation_Criteria/ 1998-02-18T12:00:00-05:00 https://reguvirta.com/posts/Day-100_Meetings_for_PMA_Applications__Procedures_and_Implementation/ 1998-02-18T12:00:00-05:00 https://reguvirta.com/posts/Premarket_Notification_Requirements_for_Esophageal_and_Tracheal_Prostheses_Including_Metal_Self-Expandable_Stents/ 1998-04-27T12:00:00-04:00 https://reguvirta.com/posts/Use_of_Published_Literature_and_Previously_Submitted_Data_in_PMA_Supplements_for_Class_III_Medical_Devices/ 1998-05-19T12:00:00-04:00 https://reguvirta.com/posts/Regulatory_Requirements_for_Medical_Device_Washers_and_Washer-Disinfectors/ 1998-06-01T12:00:00-04:00 https://reguvirta.com/posts/AC-Powered_Slit_Lamp_Biomicroscopes_-_Requirements_for_510k_Submissions/ 1998-07-07T12:00:00-04:00 https://reguvirta.com/posts/Uniform_Contraceptive_Device_Labeling_for_Pregnancy_and_STD_Protection_Information/ 1998-07-22T12:00:00-04:00 https://reguvirta.com/posts/Male_Latex_Condoms_-_Abbreviated_510k_Submissions_Using_Consensus_Standards/ 1998-07-23T12:00:00-04:00 https://reguvirta.com/posts/Adding_Lens_Finishing_Laboratories_to_Class_III_Rigid_Gas_Permeable_Contact_Lens_PMAs/ 1998-08-10T12:00:00-04:00 https://reguvirta.com/posts/Accidental_Radioactive_Contamination_of_Human_Food_and_Animal_Feeds__Recommendations_for_State_and_Local_Agencies/ 1998-08-13T12:00:00-04:00 https://reguvirta.com/posts/Premarket_Notification_Requirements_for_Over-The-Counter_Denture_Products_and_Repair_Kits/ 1998-08-17T12:00:00-04:00 https://reguvirta.com/posts/Powered_Suction_Pump_510k_Submissions__Information_Requirements_and_Testing_Recommendations/ 1998-09-29T12:00:00-04:00 https://reguvirta.com/posts/Nonprescription_Sunglasses_-_Requirements_for_Class_I_Over-The-Counter_Devices/ 1998-10-08T12:00:00-04:00 https://reguvirta.com/posts/Noise_Claims_in_Labeling_for_Air_Conduction_Hearing_Aids/ 1998-10-20T12:00:00-04:00 https://reguvirta.com/posts/General_vs._Specific_Indications_for_Use_in_Medical_Device_Substantial_Equivalence_Determinations/ 1998-11-03T12:00:00-05:00 https://reguvirta.com/posts/Diagnostic_Electrocardiograph_Devices_-_Performance_Testing_and_Safety_Requirements/ 1998-11-04T12:00:00-05:00 https://reguvirta.com/posts/Premarket_Notification_Requirements_for_Cardiac_Monitors,_Heart_Rate_Meters,_and_Alarms/ 1998-11-04T12:00:00-05:00 https://reguvirta.com/posts/Documentation_Requirements_for_Medical_Devices_Containing_Animal-Derived_Materials/ 1998-11-06T12:00:00-05:00 https://reguvirta.com/posts/Categories_of_Research_Eligible_for_Expedited_IRB_Review/ 1998-11-09T12:00:00-05:00 https://reguvirta.com/posts/Aqueous_Shunts_for_Glaucoma_Treatment_-_Testing_and_Documentation_Requirements/ 1998-11-15T12:00:00-05:00 https://reguvirta.com/posts/Non-Automated_Sphygmomanometers_-_Testing_and_Documentation_Requirements/ 1998-11-18T12:00:00-05:00 https://reguvirta.com/posts/Premarket_Notification_Requirements_for_Radionuclide_Dose_Calibrators/ 1998-11-19T12:00:00-05:00 https://reguvirta.com/posts/Content_Considerations_for_510k_Submissions_of_Emission_Computed_Tomography_and_Nuclear_Tomography_Systems/ 1998-12-02T12:00:00-05:00 https://reguvirta.com/posts/Labeling_Claims_for_Natural_Rubber_Medical_Devices_with_Reduced_Potential_for_Chemical_Sensitization/ 1999-01-12T12:00:00-05:00 https://reguvirta.com/posts/Premarket_Notification_Requirements_for_Dermabrasion_Devices/ 1999-03-01T12:00:00-05:00 https://reguvirta.com/posts/Preparation_of_510k_Submissions_for_General_Surgical_Meshes/ 1999-03-01T12:00:00-05:00 https://reguvirta.com/posts/Keratoprostheses_-_Special_Controls_and_Testing_Requirements_for_510k_Submissions/ 1999-03-02T12:00:00-05:00 https://reguvirta.com/posts/Promotion_and_Recruitment_for_Investigational_Medical_Devices/ 1999-03-19T12:00:00-05:00 https://reguvirta.com/posts/Immunological_Testing_for_Medical_Devices__Evaluation_and_Assessment_of_Adverse_Effects/ 1999-05-05T12:00:00-04:00 https://reguvirta.com/posts/Clinical_Study_Design_for_Cardiac_Ablation_Systems_in_Treatment_of_Ventricular_Tachycardia/ 1999-05-07T12:00:00-04:00 https://reguvirta.com/posts/Powered_Muscle_Stimulator_Premarket_Notification_510k_Submissions/ 1999-06-08T12:00:00-04:00 https://reguvirta.com/posts/Inferior_Vena_Cava_Filters_-_Testing_and_Labeling_Requirements/ 1999-11-25T12:00:00-05:00 https://reguvirta.com/posts/Liquid_Chemical_Sterilants_and_High_Level_Disinfectants_-_Content_and_Format_of_510k_Submissions/ 2000-01-02T12:00:00-05:00 https://reguvirta.com/posts/Preparation_of_IDE_Applications_for_Spinal_Systems__Pedicle_Screws,_Intervertebral_Body_Fusion,_Vertebral_Body_Replacement,_and_Disc_Replacement_Devices/ 2000-01-12T12:00:00-05:00 https://reguvirta.com/posts/Premarket_Notification_Requirements_for_Penile_Rigidity_Implants/ 2000-01-15T12:00:00-05:00 https://reguvirta.com/posts/Premarket_Requirements_for_Nitric_Oxide_Delivery_Systems_and_Gas_Analyzers/ 2000-01-24T12:00:00-05:00 https://reguvirta.com/posts/Testing_Requirements_for_Metallic_Plasma_Sprayed_Coatings_on_Orthopedic_Implants/ 2000-02-01T12:00:00-05:00 https://reguvirta.com/posts/ENT_Endoscope_Sheaths_-_Requirements_for_510k_Submissions/ 2000-03-11T12:00:00-05:00 https://reguvirta.com/posts/Orthokeratology_Rigid_Gas_Permeable_Contact_Lenses_-_Premarket_Submissions_and_Clinical_Testing_Requirements/ 2000-04-09T12:00:00-04:00 https://reguvirta.com/posts/Consolidated_Annual_Reporting_for_Pacemaker_Product_Lines_(1-CARD)/ 2000-07-05T12:00:00-04:00 https://reguvirta.com/posts/Over-the-Counter_Pregnancy_Test_Devices_-_510k_Submission_Requirements_and_Performance_Standards/ 2000-07-21T12:00:00-04:00 https://reguvirta.com/posts/Content_Considerations_for_Superficial_and_Interstitial_Photon-Emitting_Radionuclide_Brachytherapy_Sources/ 2000-08-01T12:00:00-04:00 https://reguvirta.com/posts/Use_of_Data_from_Approved_PMAs_to_Support_New_Device_Approvals_After_6_Years/ 2000-08-08T12:00:00-04:00 https://reguvirta.com/posts/Labeling_for_Electronic_Anti-Theft_Systems_to_Alert_Implantable_Medical_Device_Wearers/ 2000-08-15T12:00:00-04:00 https://reguvirta.com/posts/Dura_Substitute_Devices_-_Premarket_Notification_(510k)_Submissions/ 2000-11-08T12:00:00-05:00 https://reguvirta.com/posts/Organ_Preservation_Solutions_for_Transplantation_-_Testing_and_Development_Requirements/ 2001-01-15T12:00:00-05:00 https://reguvirta.com/posts/Early_Collaboration_Meetings_for_Medical_Device_Development__Determination_and_Agreement_Procedures/ 2001-02-27T12:00:00-05:00 https://reguvirta.com/posts/Writing_Medical_Device_Patient_Labeling__Content_and_Design_Considerations/ 2001-04-19T12:00:00-04:00 https://reguvirta.com/posts/Laser_Light_Show_Projectors_-_Variance_Requirements_and_Safety_Standards/ 2001-05-26T12:00:00-04:00 https://reguvirta.com/posts/Changes_to_Investigational_Device_Exemption_(IDE)_Protocols_and_When_FDA_Approval_is_Required/ 2001-05-28T12:00:00-04:00 https://reguvirta.com/posts/Labeling_Requirements_for_Keratomes_Used_in_LASIK_Surgery/ 2001-06-20T12:00:00-04:00 https://reguvirta.com/posts/Reprocessing_of_Single-Use_Medical_Devices__Requirements_for_Third-Party_and_Hospital_Reprocessors/ 2001-07-06T12:00:00-04:00 https://reguvirta.com/posts/Labeling_Requirements_for_Reprocessed_Single-Use_Medical_Devices/ 2001-07-30T12:00:00-04:00 https://reguvirta.com/posts/Sterilization_of_Convenience_Kits__Component_Compatibility_and_Validation_Requirements/ 2002-01-07T12:00:00-05:00 https://reguvirta.com/posts/Software_Validation_for_Medical_Device_Production,_Quality_Systems,_and_Device_Components/ 2002-01-11T12:00:00-05:00 https://reguvirta.com/posts/Resorbable_Adhesion_Barrier_Devices_for_Abdominal_and_Pelvic_Use_-_Development_and_Testing_Requirements/ 2002-06-17T12:00:00-04:00 https://reguvirta.com/posts/Military_Laser_Products__Department_of_Defense_Exemption_Requirements_and_Compliance_Process/ 2002-07-12T12:00:00-04:00 https://reguvirta.com/posts/Medical_Device_Reporting_for_Needlestick_and_Other_Sharps_Injuries/ 2002-11-11T12:00:00-05:00 https://reguvirta.com/posts/Determining_and_Managing_Off-Label_Use_Concerns_in_510k_Submissions/ 2002-12-02T12:00:00-05:00 https://reguvirta.com/posts/Quality_System_Information_Requirements_for_Premarket_Submissions/ 2003-02-03T12:00:00-05:00 https://reguvirta.com/posts/Pediatric_Expertise_for_Advisory_Panels_Reviewing_Medical_Device_Submissions/ 2003-06-02T12:00:00-04:00 https://reguvirta.com/posts/Registration_and_Listing_Requirements_for_Single-Use_Device_Reprocessors_and_Hospitals/ 2003-07-16T12:00:00-04:00 https://reguvirta.com/posts/Assembly,_Installation,_Adjustment_and_Testing_Information_Requirements_for_Diagnostic_X-Ray_Systems/ 2003-09-04T12:00:00-04:00 https://reguvirta.com/posts/Electronic_Records_and_Electronic_Signatures_-_Scope_and_Application/ 2003-09-05T12:00:00-04:00 https://reguvirta.com/posts/Chemical_Indicators_for_Sterilization_Process_Monitoring_in_Healthcare_Facilities_-_Content_and_Format_Requirements_for_510k_Submissions/ 2003-12-18T12:00:00-05:00 https://reguvirta.com/posts/Vocal_Fold_Medialization_Devices_-_Testing_and_Documentation_Requirements/ 2004-02-12T12:00:00-05:00 https://reguvirta.com/posts/Performance_Testing_and_Labeling_Requirements_for_Surgical_and_Medical_Face_Masks/ 2004-03-04T12:00:00-05:00 https://reguvirta.com/posts/Spinal_Plating_Systems_and_Vertebral_Body_Replacement_Devices_-_Content_and_Testing_Requirements_for_510k_Submissions/ 2004-05-02T12:00:00-04:00 https://reguvirta.com/posts/Dispute_Resolution_Process_for_Combination_Product_Review_Timelines/ 2004-05-03T12:00:00-04:00 https://reguvirta.com/posts/Validation_Data_Requirements_for_Reprocessed_Single-Use_Medical_Devices/ 2004-06-02T12:00:00-04:00 https://reguvirta.com/posts/Clinical_Studies_for_Vertebral_Body_Augmentation_Devices_in_Treatment_of_Insufficiency_Fractures/ 2004-10-23T12:00:00-04:00 https://reguvirta.com/posts/Clinical_Data_Presentation_for_Orthopedic_Implant_Device_Submissions/ 2004-12-01T12:00:00-05:00 https://reguvirta.com/posts/Cybersecurity_Maintenance_for_Medical_Devices_with_Off-The-Shelf_Software/ 2005-01-14T12:00:00-05:00 https://reguvirta.com/posts/Cybersecurity_for_Networked_Medical_Devices_with_Off-The-Shelf_Software/ 2005-02-08T12:00:00-05:00 https://reguvirta.com/posts/Regulatory_Actions_and_Civil_Penalties_for_Non-Compliant_Diagnostic_X-ray_Equipment_Assemblers/ 2005-02-28T12:00:00-05:00 https://reguvirta.com/posts/Regulatory_Requirements_and_Enforcement_Actions_for_Defective_Sunlamp_Products_Manufactured_Before_May_7,_1980/ 2005-02-28T12:00:00-05:00 https://reguvirta.com/posts/X-ray_Tube_Housing_Assembly_Reloading_Facilities__Registration,_Listing_and_Inspection_Requirements/ 2005-02-28T12:00:00-05:00 https://reguvirta.com/posts/Pharmacogenomic_Data_Submissions_in_Drug_Development_and_Biomarker_Classification/ 2005-03-01T12:00:00-05:00 https://reguvirta.com/posts/Civil_Penalties_for_Electronic_Product_Radiation_Control_Violations/ 2005-04-01T12:00:00-05:00 https://reguvirta.com/posts/Menstrual_Tampons_and_Menstrual_Pads_-_Testing_and_Labeling_Requirements_for_510k_Submissions/ 2005-07-26T12:00:00-04:00 https://reguvirta.com/posts/Medical_Devices_with_Sharps_Injury_Prevention_Features_-_Testing,_Documentation_and_Labeling_Requirements/ 2005-08-08T12:00:00-04:00 https://reguvirta.com/posts/C-Reactive_Protein_(CRP)_Assays_-_Premarket_Notification_510k_Submissions/ 2005-09-22T12:00:00-04:00 https://reguvirta.com/posts/Premarket_Notification_Requirements_for_Dental_Composite_Resin_Materials/ 2005-10-25T12:00:00-04:00 https://reguvirta.com/posts/High-Intensity_Mercury_Vapor_Discharge_Lamps__Scope_of_Performance_Standard_and_Requirements_for_General_Purpose_Lighting_vs._Specialized_Applications/ 2005-11-05T12:00:00-05:00 https://reguvirta.com/posts/Exemption_from_Reporting_Requirements_for_Low_Risk_Class_I_Laser_Products/ 2006-01-05T12:00:00-05:00 https://reguvirta.com/posts/Electronic_Submission_Format_Requirements_for_Orphan_Drug_and_Humanitarian_Use_Device_Designation_Requests/ 2006-02-01T12:00:00-05:00 https://reguvirta.com/posts/Pharmacogenetic_Tests__Premarket_Submission_Requirements_and_Performance_Validation/ 2006-02-09T12:00:00-05:00 https://reguvirta.com/posts/Electronic_Distribution_of_Product_Information_and_Safety_Communications/ 2006-02-28T12:00:00-05:00 https://reguvirta.com/posts/Hospital_Bed_System_Dimensional_and_Safety_Requirements_to_Reduce_Patient_Entrapment/ 2006-03-10T12:00:00-05:00 https://reguvirta.com/posts/Dental_Curing_Lights_-_Performance_Testing_and_Safety_Requirements/ 2006-03-27T12:00:00-05:00 https://reguvirta.com/posts/Tonometers_for_Measuring_Intraocular_Pressure_-_Testing_and_Performance_Requirements/ 2006-03-27T12:00:00-05:00 https://reguvirta.com/posts/Establishment_and_Operation_of_Clinical_Trial_Data_Monitoring_Committees/ 2006-03-28T12:00:00-05:00 https://reguvirta.com/posts/Use_of_Leftover_Human_Specimens_in_IVD_Device_Studies__Requirements_for_IDE_Exemption_and_Privacy_Protection/ 2006-04-25T12:00:00-04:00 https://reguvirta.com/posts/Color_Additives_in_Contact_Lenses__Preparing_and_Submitting_Petitions/ 2006-05-01T12:00:00-04:00 https://reguvirta.com/posts/Reprocessor_Identification_Requirements_for_Reprocessed_Single-Use_Devices/ 2006-05-01T12:00:00-04:00 https://reguvirta.com/posts/Early_Development_Considerations_for_Combination_Products/ 2006-09-01T12:00:00-04:00 https://reguvirta.com/posts/Keratomes_and_Replacement_Keratome_Blades_for_Corneal_Surgery/ 2006-09-18T12:00:00-04:00 https://reguvirta.com/posts/Regulatory_Requirements_for_Decorative_Non-Corrective_Contact_Lenses/ 2006-11-24T12:00:00-05:00 https://reguvirta.com/posts/Process_for_Clinical_Investigations_Involving_Children_Requiring_Additional_Safeguards/ 2006-12-01T12:00:00-05:00 https://reguvirta.com/posts/Regulatory_Framework_for_Complementary_and_Alternative_Medicine_Products/ 2007-02-27T12:00:00-05:00 https://reguvirta.com/posts/Statistical_Guidance_for_Reporting_Diagnostic_Test_Results_with_Qualitative_Outcomes/ 2007-03-12T12:00:00-04:00 https://reguvirta.com/posts/Alternative_Labeling_Methods_for_Laser_Products/ 2007-03-22T12:00:00-04:00 https://reguvirta.com/posts/Dental_Handpieces_-_Performance_Testing,_Safety_Requirements_and_Labeling/ 2007-05-02T12:00:00-04:00 https://reguvirta.com/posts/Neurothrombectomy_Devices_for_Acute_Ischemic_Stroke_Treatment_-_Pre-clinical_and_Clinical_Testing/ 2007-06-18T12:00:00-04:00 https://reguvirta.com/posts/Bundling_Multiple_Devices_and_Multiple_Indications_in_Medical_Device_Submissions/ 2007-06-22T12:00:00-04:00 https://reguvirta.com/posts/Jurisdictional_Determinations_for_HCT_P_Processing_Devices__CBER_vs_CDRH_Assignment/ 2007-07-01T12:00:00-04:00 https://reguvirta.com/posts/Dear_Doctor_Letters_for_Implantable_Cardioverter_Defibrillator_Recalls__Content_and_Format_Recommendations/ 2007-07-19T12:00:00-04:00 https://reguvirta.com/posts/Marketing_and_Distribution_Requirements_for_Analyte_Specific_Reagents_(ASRs)/ 2007-09-13T12:00:00-04:00 https://reguvirta.com/posts/Non-Clinical_Testing_and_Labeling_Requirements_for_Femoral_Stem_Prostheses_in_Hip_Replacement_Systems/ 2007-09-17T12:00:00-04:00 https://reguvirta.com/posts/Safety_and_Performance_Requirements_for_Cabinet_X-ray_Security_Screening_and_Industrial_Quality_Control_Systems/ 2007-09-18T12:00:00-04:00 https://reguvirta.com/posts/Laser_Light_Show_Variance_Renewal_and_Amendment_Procedures/ 2007-09-24T12:00:00-04:00 https://reguvirta.com/posts/Biological_Indicators_for_Healthcare_Facility_Sterilization_Process_Monitoring_-_510k_Submission_Requirements/ 2007-10-04T12:00:00-04:00 https://reguvirta.com/posts/Inspection_and_Field_Testing_Requirements_for_Radiation-Emitting_Electronic_Products/ 2007-10-30T12:00:00-04:00 https://reguvirta.com/posts/Inspection_and_Field_Testing_Requirements_for_Sunlamp_Products_and_UV-Emitting_Devices/ 2007-10-30T12:00:00-04:00 https://reguvirta.com/posts/Manufacturing_Site_Inspections_and_PMA_Review_Process_for_Medical_Devices/ 2008-01-08T12:00:00-05:00 https://reguvirta.com/posts/Medical_Gloves_-_Premarket_Notification,_Quality_System,_Labeling_and_Compliance_Requirements/ 2008-01-22T12:00:00-05:00 https://reguvirta.com/posts/Coronary_and_Carotid_Embolic_Protection_Devices_-_Performance_Testing_and_Labeling_Requirements/ 2008-02-15T12:00:00-05:00 https://reguvirta.com/posts/Container_and_Closure_System_Integrity_Testing_as_an_Alternative_to_Sterility_Testing_for_Stability_Protocols/ 2008-02-25T12:00:00-05:00 https://reguvirta.com/posts/Total_Artificial_Disc_Devices_-_Pre-clinical_Testing_and_Clinical_Trial_Design_Requirements/ 2008-04-11T12:00:00-04:00 https://reguvirta.com/posts/Clinical_Investigation_of_Nocturnal_Home_Hemodialysis_Delivery_Systems/ 2008-04-15T12:00:00-04:00 https://reguvirta.com/posts/Hemodialysis_Blood_Tubing_Sets_-_Performance,_Testing,_and_Labeling_Requirements/ 2008-04-23T12:00:00-04:00 https://reguvirta.com/posts/Import_Surveillance_and_Detention_Process_for_Condoms_Failing_Water_Leak_Testing_Requirements/ 2008-07-11T12:00:00-04:00 https://reguvirta.com/posts/Import_Surveillance_and_Detention_of_Medical_Gloves_that_Fail_Water_Leak_Testing/ 2008-07-11T12:00:00-04:00 https://reguvirta.com/posts/Intravascular_Administration_Sets_and_Accessories_-_Testing_and_Documentation_Requirements/ 2008-07-11T12:00:00-04:00 https://reguvirta.com/posts/Preparation_and_Submission_of_Advisory_Committee_Briefing_Materials_for_Public_Release/ 2008-08-01T12:00:00-04:00 https://reguvirta.com/posts/Voting_Procedures_for_Advisory_Committee_Meetings/ 2008-08-01T12:00:00-04:00 https://reguvirta.com/posts/Clinical_Study_Design_Recommendations_for_Catheter_Ablation_Devices_in_Treatment_of_Type_I_Atrial_Flutter/ 2008-08-05T12:00:00-04:00 https://reguvirta.com/posts/Data_Retention_Requirements_When_Clinical_Trial_Subjects_Withdraw_from_FDA-Regulated_Studies/ 2008-10-01T12:00:00-04:00 https://reguvirta.com/posts/Modifications_to_PMA-Approved_Class_III_Medical_Devices__Selecting_the_Appropriate_Regulatory_Submission_Type/ 2008-12-11T12:00:00-05:00 https://reguvirta.com/posts/Safety_Considerations_for_Hand-Held_X-Ray_Equipment__Radiation_Protection_and_Testing_Requirements/ 2008-12-23T12:00:00-05:00 https://reguvirta.com/posts/Adverse_Event_Reporting_to_IRBs_Under_FDA-Regulated_Research/ 2009-01-14T12:00:00-05:00 https://reguvirta.com/posts/Color_Additive_Petitions__Chemical_and_Technical_Requirements_for_Food,_Drugs,_Cosmetics,_and_Medical_Devices/ 2009-07-01T12:00:00-04:00 https://reguvirta.com/posts/IRB_Registration_Requirements_and_Procedures/ 2009-07-09T12:00:00-04:00 https://reguvirta.com/posts/Investigator_Responsibilities_-_Protecting_Human_Subjects_and_Ensuring_Data_Integrity_in_Clinical_Research/ 2009-10-23T12:00:00-04:00 https://reguvirta.com/posts/Patient-Reported_Outcome_Measures__Development,_Implementation_and_Evaluation_in_Clinical_Trials/ 2009-12-09T12:00:00-05:00 https://reguvirta.com/posts/Adding_Imaging_Contrast_Indications_to_Medical_Devices_Used_with_Approved_Imaging_Drugs/ 2010-01-06T12:00:00-05:00 https://reguvirta.com/posts/Bayesian_Statistics_in_Medical_Device_Clinical_Trials__Design,_Analysis_and_Implementation/ 2010-02-04T12:00:00-05:00 https://reguvirta.com/posts/Bayesian_Statistics_in_Medical_Device_Clinical_Trials/ 2010-02-05T12:00:00-05:00 https://reguvirta.com/posts/Non-Clinical_Testing_and_Labeling_Requirements_for_Extracranial_Intravascular_Stents_and_Delivery_Systems/ 2010-04-17T12:00:00-04:00 https://reguvirta.com/posts/In_Vitro_Diagnostic_Device_Studies_Exempt_from_Investigational_Device_Exemption_Requirements/ 2010-06-25T12:00:00-04:00 https://reguvirta.com/posts/Contact_Lens_Care_Product_Labeling__Warnings,_Instructions_and_Readability_Requirements/ 2010-08-15T12:00:00-04:00 https://reguvirta.com/posts/Impact-Resistant_Lenses_in_Eyeglasses_and_Sunglasses__Testing,_Documentation,_and_Import_Requirements/ 2010-09-02T12:00:00-04:00 https://reguvirta.com/posts/Including_Manufacturer's_URL_on_Electronic_Product_Labels/ 2010-09-29T12:00:00-04:00 https://reguvirta.com/posts/Blood_Lancets_-_Single_Patient_Use_Only_Labeling_Requirements/ 2010-11-28T12:00:00-05:00 https://reguvirta.com/posts/Clinical_Investigation_of_Medical_Devices_for_Treatment_of_Urinary_Incontinence/ 2011-03-07T12:00:00-05:00 https://reguvirta.com/posts/How_to_Submit_a_Request_for_Designation_(RFD)_for_Product_Classification_and_FDA_Center_Assignment/ 2011-04-14T12:00:00-04:00 https://reguvirta.com/posts/In_Vitro_Diagnostic_Devices_for_Detection_and_Differentiation_of_Influenza_Viruses_-_Performance_Testing_and_Validation_Requirements/ 2011-07-14T12:00:00-04:00 https://reguvirta.com/posts/Exculpatory_Language_in_Informed_Consent_Documents_for_Clinical_Research/ 2011-08-19T12:00:00-04:00 https://reguvirta.com/posts/Continuing_Review_of_Clinical_Investigations_by_Institutional_Review_Boards_(IRBs)/ 2012-02-27T12:00:00-05:00 https://reguvirta.com/posts/The_Content_and_Development_of_Premarket_Submissions_for_Artificial_Pancreas_Device_Systems/ 2012-11-09T12:00:00-05:00 https://reguvirta.com/posts/Postapproval_Changes_to_Combination_Products__Marketing_Submission_Requirements/ 2013-01-18T12:00:00-05:00 https://reguvirta.com/posts/Financial_Disclosure_Requirements_for_Clinical_Investigators/ 2013-02-01T12:00:00-05:00 https://reguvirta.com/posts/Clinical_Study_Design_for_Surgical_Ablation_Devices_Used_in_Treatment_of_Atrial_Fibrillation_Under_Direct_Visualization/ 2013-02-14T12:00:00-05:00 https://reguvirta.com/posts/Pulse_Oximeters_-_Performance_Testing_and_Safety_Requirements_for_SpO2_and_Pulse_Rate_Measurement_Devices/ 2013-03-03T12:00:00-05:00 https://reguvirta.com/posts/Retinal_Prostheses__Clinical,_Non-Clinical,_and_Safety_Recommendations_for_Electrical_Stimulation_Devices/ 2013-03-06T12:00:00-05:00 https://reguvirta.com/posts/In_Vitro_Diagnostic_Devices_for_Detection_of_Antibodies_to_Borrelia_burgdorferi_-_Performance_Characteristics_and_Testing_Requirements/ 2013-03-27T12:00:00-04:00 https://reguvirta.com/posts/Glass_Syringes__Testing_and_Performance_Requirements_for_Connectivity_with_Needles_and_Other_Devices/ 2013-03-31T12:00:00-04:00 https://reguvirta.com/posts/Exception_from_Informed_Consent_Requirements_for_Emergency_Research/ 2013-04-01T12:00:00-04:00 https://reguvirta.com/posts/Medical_Device_Product_Code_Usage_and_Requirements/ 2013-04-10T12:00:00-04:00 https://reguvirta.com/posts/Migration_Studies_for_In_Vitro_Diagnostic_Devices_Moving_to_New_Systems/ 2013-04-25T12:00:00-04:00 https://reguvirta.com/posts/Public_Participation_in_Open_Public_Hearing_Sessions_of_Advisory_Committee_Meetings/ 2013-05-15T12:00:00-04:00 https://reguvirta.com/posts/Technical_Considerations_for_Pen,_Jet,_and_Related_Injectors_Submitted_in_Drug_and_Biological_Product_Applications/ 2013-06-07T12:00:00-04:00 https://reguvirta.com/posts/Risk-Based_Monitoring_in_Clinical_Investigations_of_Medical_Products/ 2013-08-07T12:00:00-04:00 https://reguvirta.com/posts/Radio_Frequency_Wireless_Technology_in_Medical_Devices/ 2013-08-14T12:00:00-04:00 https://reguvirta.com/posts/IRB_Responsibilities_for_Reviewing_Investigator_Qualifications,_Research_Sites,_and_IND_IDE_Requirements/ 2013-08-27T12:00:00-04:00 https://reguvirta.com/posts/Electronic_Source_Data_in_Clinical_Investigations/ 2013-09-18T12:00:00-04:00 https://reguvirta.com/posts/Early_Feasibility_Medical_Device_Clinical_Studies_Including_First_in_Human_(FIH)_Studies/ 2013-10-01T12:00:00-04:00 https://reguvirta.com/posts/Design_Considerations_for_Medical_Device_Pivotal_Clinical_Studies/ 2013-11-07T12:00:00-05:00 https://reguvirta.com/posts/Research_Use_Only_and_Investigational_Use_Only_In_Vitro_Diagnostic_Products_-_Labeling_and_Distribution_Requirements/ 2013-11-25T12:00:00-05:00 https://reguvirta.com/posts/Electronic_Medical_Device_Reporting__Questions_and_Answers_on_Electronic_Submission_of_Postmarket_Reports/ 2014-02-13T12:00:00-05:00 https://reguvirta.com/posts/Public_Disclosure_of_Advisory_Committee_Members'_Financial_Interests_and_Waivers/ 2014-02-28T12:00:00-05:00 https://reguvirta.com/posts/Premarket_Assessment_of_Medical_Devices_for_Pediatric_Use/ 2014-03-24T12:00:00-04:00 https://reguvirta.com/posts/Medical_Device_Tracking_Requirements_and_Implementation_Procedures/ 2014-03-27T12:00:00-04:00 https://reguvirta.com/posts/Same-Sex_Marriage_Recognition_in_Regulatory_Definitions_of_Spouse_and_Family/ 2014-03-31T12:00:00-04:00 https://reguvirta.com/posts/Types_of_Communication_During_Medical_Device_Submissions_Review/ 2014-04-04T12:00:00-04:00 https://reguvirta.com/posts/Providing_Pediatric_Use_Information_for_Medical_Device_Premarket_Submissions_Under_Section_515A/ 2014-05-01T12:00:00-04:00 https://reguvirta.com/posts/Transfer_of_Clinical_Investigation_Oversight_Between_Institutional_Review_Boards/ 2014-05-23T12:00:00-04:00 https://reguvirta.com/posts/Criteria_for_Significant_Risk_Investigations_of_Magnetic_Resonance_Diagnostic_Devices/ 2014-06-19T12:00:00-04:00 https://reguvirta.com/posts/Considering_Whether_FDA-Regulated_Products_Involve_Nanotechnology/ 2014-06-23T12:00:00-04:00 https://reguvirta.com/posts/Content_and_Decision-Making_Process_for_510k_Submissions__Determining_Substantial_Equivalence/ 2014-07-28T12:00:00-04:00 https://reguvirta.com/posts/In_Vitro_Companion_Diagnostic_Devices__Development,_Review_Process,_and_Labeling_Requirements/ 2014-08-06T12:00:00-04:00 https://reguvirta.com/posts/IDE_Clinical_Investigation_Decision_Process_and_Requirements/ 2014-08-19T12:00:00-04:00 https://reguvirta.com/posts/Unique_Device_Identification_System__Implementation_and_Compliance_Requirements/ 2014-08-20T12:00:00-04:00 https://reguvirta.com/posts/Highly_Multiplexed_Microbiological_Medical_Countermeasure_In_Vitro_Nucleic_Acid_Based_Diagnostic_Devices/ 2014-08-27T12:00:00-04:00 https://reguvirta.com/posts/Custom_Device_Exemption_Requirements_and_Implementation/ 2014-09-24T12:00:00-04:00 https://reguvirta.com/posts/Distinguishing_Between_Medical_Device_Recalls_and_Device_Enhancements/ 2014-10-15T12:00:00-04:00 https://reguvirta.com/posts/Dual_Use_Molecular_Diagnostic_Instruments_with_FDA-Approved_and_Non-Approved_Functions/ 2014-11-12T12:00:00-05:00 https://reguvirta.com/posts/Design_Considerations_for_Medical_Devices_Intended_for_Home_Use/ 2014-11-24T12:00:00-05:00 https://reguvirta.com/posts/Infusion_Pumps_-_Total_Product_Life_Cycle_Recommendations_for_Safety_and_Performance/ 2014-12-02T12:00:00-05:00 https://reguvirta.com/posts/Recommendations_for_Labeling_Medical_Products_Without_Natural_Rubber_Latex/ 2014-12-02T12:00:00-05:00 https://reguvirta.com/posts/Safety_of_Children's_Toy_Laser_Products/ 2014-12-19T12:00:00-05:00 https://reguvirta.com/posts/Safety_and_Performance_of_Enteral_Device_Connectors_to_Reduce_Misconnection_Risks/ 2015-02-11T12:00:00-05:00 https://reguvirta.com/posts/Reprocessing_Instructions_for_Reusable_Medical_Devices_and_Non-Sterile_Single-Use_Devices_-_Development_and_Validation/ 2015-03-17T12:00:00-04:00 https://reguvirta.com/posts/Balancing_Pre-Market_and_Post-Market_Data_Collection_for_PMA_Medical_Devices/ 2015-04-13T12:00:00-04:00 https://reguvirta.com/posts/Early_Growth_Response_1_(EGR1)_Gene_Fluorescence_In-Situ_Hybridization_Test_Systems_for_Bone_Marrow_Specimens/ 2015-06-17T12:00:00-04:00 https://reguvirta.com/posts/Meetings_with_the_Office_of_Orphan_Products_Development__Procedures_and_Best_Practices/ 2015-07-09T12:00:00-04:00 https://reguvirta.com/posts/Endotoxin_Testing_for_Single-Use_Intraocular_Ophthalmic_Devices/ 2015-08-17T12:00:00-04:00 https://reguvirta.com/posts/Corrosion_Testing_and_Surface_Characterization_Requirements_for_Intravascular_Stents/ 2015-08-18T12:00:00-04:00 https://reguvirta.com/posts/Premarket_Regulatory_Requirements_for_Liquid_Barrier_Protection_Claims_in_Medical_Gowns/ 2015-12-09T12:00:00-05:00 https://reguvirta.com/posts/Implantable_Minimally_Invasive_Glaucoma_Surgical_(MIGS)_Devices_-_Testing_and_Clinical_Requirements/ 2015-12-15T12:00:00-05:00 https://reguvirta.com/posts/Special_Controls_for_Implanted_Blood_Access_Devices_for_Hemodialysis/ 2016-01-21T12:00:00-05:00 https://reguvirta.com/posts/Applying_Human_Factors_Engineering_and_Usability_Engineering_to_Medical_Devices/ 2016-02-03T12:00:00-05:00 https://reguvirta.com/posts/List_of_Device_Types_That_Require_Human_Factors_Data_in_Premarket_Submissions/ 2016-02-03T12:00:00-05:00 https://reguvirta.com/posts/Assay_Development_and_Validation_Requirements_for_Lamotrigine_and_Zonisamide_Testing_in_Clinical_Laboratories/ 2016-02-09T12:00:00-05:00 https://reguvirta.com/posts/Clinical_Trial_Design_and_Regulatory_Considerations_for_Nail_Appearance_and_Onychomycosis_Treatment_Devices/ 2016-03-07T12:00:00-05:00 https://reguvirta.com/posts/Assessment_of_Radiofrequency-Induced_Heating_in_Multi-Configuration_Passive_Medical_Devices_for_MR_Conditional_Labeling/ 2016-03-22T12:00:00-04:00 https://reguvirta.com/posts/Radiation_Biodosimetry_Devices__Performance_Testing_and_Documentation_Requirements/ 2016-04-18T12:00:00-04:00 https://reguvirta.com/posts/Technical_Performance_Assessment_of_Digital_Whole_Slide_Imaging_Systems_in_Anatomic_Pathology/ 2016-04-20T12:00:00-04:00 https://reguvirta.com/posts/Leveraging_Existing_Clinical_Data_for_Pediatric_Medical_Device_Indications/ 2016-06-21T12:00:00-04:00 https://reguvirta.com/posts/Evaluating_Appearance_Issues_and_Granting_Participation_Authorizations_for_Advisory_Committee_Members/ 2016-06-29T12:00:00-04:00 https://reguvirta.com/posts/In_Vitro_Companion_Diagnostic_Device_and_Therapeutic_Product_Co-Development/ 2016-07-15T12:00:00-04:00 https://reguvirta.com/posts/Adaptive_Designs_for_Medical_Device_Clinical_Studies/ 2016-07-27T12:00:00-04:00 https://reguvirta.com/posts/Bipolar_Electrosurgical_Vessel_Sealers_for_General_Surgery_-_Performance_Testing_and_Labeling_Requirements/ 2016-08-15T12:00:00-04:00 https://reguvirta.com/posts/Patient_Preference_Information_in_Medical_Device_Development,_Clinical_Trials,_and_Regulatory_Decision_Making/ 2016-08-24T12:00:00-04:00 https://reguvirta.com/posts/Solid_State_X-ray_Imaging_Devices_for_Medical_Diagnostic_Use/ 2016-09-01T12:00:00-04:00 https://reguvirta.com/posts/Reporting_of_Computational_Modeling_and_Simulation_Studies_in_Medical_Device_Submissions/ 2016-09-21T12:00:00-04:00 https://reguvirta.com/posts/Collection_and_Reporting_of_Race_and_Ethnicity_Data_in_Clinical_Trials/ 2016-10-26T12:00:00-04:00 https://reguvirta.com/posts/Labeling_Requirements_for_Permanent_Hysteroscopic_Tubal_Implants_for_Female_Sterilization/ 2016-10-31T12:00:00-04:00 https://reguvirta.com/posts/Clinical_Trial_Considerations_for_Neurological_Devices_Intended_to_Slow,_Stop,_or_Reverse_Disease_Progression/ 2016-11-07T12:00:00-05:00 https://reguvirta.com/posts/Medical_Device_Reporting_(MDR)_Requirements_and_Procedures_for_Manufacturers/ 2016-11-08T12:00:00-05:00 https://reguvirta.com/posts/Mitigating_Cross-Contamination_Risks_in_Irrigation_Valves_and_Accessories_Used_with_Flexible_Gastrointestinal_Endoscopes/ 2016-11-29T12:00:00-05:00 https://reguvirta.com/posts/Public_Notification_of_Medical_Device_Emerging_Signals__New_Safety_Information_and_Adverse_Events/ 2016-12-14T12:00:00-05:00 https://reguvirta.com/posts/Use_of_Electronic_Informed_Consent_in_Clinical_Investigations/ 2016-12-15T12:00:00-05:00 https://reguvirta.com/posts/Benefit-Risk_Factors_in_Medical_Device_Product_Availability,_Compliance,_and_Enforcement_Decisions/ 2016-12-27T12:00:00-05:00 https://reguvirta.com/posts/Postmarket_Management_of_Cybersecurity_in_Medical_Devices/ 2016-12-28T12:00:00-05:00 https://reguvirta.com/posts/Current_Good_Manufacturing_Practice_Requirements_for_Combination_Products/ 2017-01-11T12:00:00-05:00 https://reguvirta.com/posts/Benefit-Risk_Factors_in_IDE_Applications_for_Medical_Device_Clinical_Investigations/ 2017-01-13T12:00:00-05:00 https://reguvirta.com/posts/Emergency_Use_Authorization_of_Medical_Products__Requirements_and_Procedures_for_Unapproved_Products_and_Uses/ 2017-01-13T12:00:00-05:00 https://reguvirta.com/posts/Certifying_Compliance_with_Clinical_Trial_Registration_Requirements_on_Form_FDA_3674/ 2017-06-07T12:00:00-04:00 https://reguvirta.com/posts/Use_of_Real-World_Data_to_Generate_Evidence_for_Medical_Device_Regulatory_Decisions/ 2017-08-31T12:00:00-04:00 https://reguvirta.com/posts/Procedures_for_Medical_Devices_Advisory_Committee_Panel_Meetings/ 2017-09-01T12:00:00-04:00 https://reguvirta.com/posts/Design_Considerations_and_Recommendations_for_Interoperable_Medical_Devices/ 2017-09-06T12:00:00-04:00 https://reguvirta.com/posts/Evaluation_and_Reporting_of_Age,_Race,_and_Ethnicity_Data_in_Medical_Device_Clinical_Studies/ 2017-09-12T12:00:00-04:00 https://reguvirta.com/posts/Establishing_Performance_Characteristics_for_Human_Papillomavirus_(HPV)_Detection_In_Vitro_Diagnostic_Devices/ 2017-09-15T12:00:00-04:00 https://reguvirta.com/posts/Classification_of_Products_as_Drugs_or_Devices__Interpretation_and_Determination_Process/ 2017-09-25T12:00:00-04:00 https://reguvirta.com/posts/Minutes_of_Institutional_Review_Board_(IRB)_Meetings_-_Content_and_Documentation_Requirements/ 2017-09-25T12:00:00-04:00 https://reguvirta.com/posts/Administrative_Procedures_for_CLIA_Categorization_of_In_Vitro_Diagnostic_Tests/ 2017-10-02T12:00:00-04:00 https://reguvirta.com/posts/Deciding_When_to_Submit_a_New_510k_for_Changes_to_an_Existing_Medical_Device/ 2017-10-25T12:00:00-04:00 https://reguvirta.com/posts/Deciding_When_to_Submit_a_New_510k_for_Software_Changes_to_Medical_Devices/ 2017-10-25T12:00:00-04:00 https://reguvirta.com/posts/Labeling_Requirements_for_Ultrasonic_Surgical_Aspirator_Devices_-_Contraindication_for_Uterine_Fibroid_Procedures/ 2017-10-30T12:00:00-04:00 https://reguvirta.com/posts/Sharing_Patient-Specific_Information_from_Medical_Devices_with_Patients/ 2017-10-30T12:00:00-04:00 https://reguvirta.com/posts/Direct_Marking_of_Devices_with_Unique_Device_Identification_(UDI)_Requirements_for_Reusable_Medical_Devices/ 2017-11-17T12:00:00-05:00 https://reguvirta.com/posts/Pediatric_X-Ray_Imaging_Device_Premarket_Submissions__Design,_Testing,_and_Labeling_Considerations/ 2017-11-28T12:00:00-05:00 https://reguvirta.com/posts/IDE_Device_Categorization_for_Medicare_Coverage__Category_A_vs_Category_B_Determination/ 2017-12-05T12:00:00-05:00 https://reguvirta.com/posts/Technical_Considerations_for_Additive_Manufactured_Medical_Devices/ 2017-12-05T12:00:00-05:00 https://reguvirta.com/posts/Clinical_Evaluation_of_Software_as_a_Medical_Device_(SaMD)/ 2017-12-08T12:00:00-05:00 https://reguvirta.com/posts/Investigational_In_Vitro_Diagnostic_Devices_Used_in_Therapeutic_Product_Clinical_Trials/ 2017-12-18T12:00:00-05:00 https://reguvirta.com/posts/Medical_Device_Accessories__Classification_and_Risk-Based_Approach/ 2017-12-20T12:00:00-05:00 https://reguvirta.com/posts/How_to_Submit_a_Pre-Request_for_Designation_(Pre-RFD)_for_Product_Classification_and_Center_Assignment/ 2018-02-14T12:00:00-05:00 https://reguvirta.com/posts/Acceptance_of_Clinical_Data_to_Support_Medical_Device_Applications_and_Submissions/ 2018-02-21T12:00:00-05:00 https://reguvirta.com/posts/Standards_for_Drug_Supply_Chain_Transaction_Information,_History_and_Statements/ 2018-03-02T12:00:00-05:00 https://reguvirta.com/posts/Use_of_Genetic_Variant_Databases_as_Sources_of_Valid_Scientific_Evidence_for_Clinical_Validity_of_Genetic_Tests/ 2018-04-13T12:00:00-04:00 https://reguvirta.com/posts/Use_of_Next_Generation_Sequencing_in_the_Diagnosis_of_Germline_Diseases/ 2018-04-13T12:00:00-04:00 https://reguvirta.com/posts/Health_Care_Economic_Information_Communications_to_Payors_for_Medical_Devices/ 2018-06-13T12:00:00-04:00 https://reguvirta.com/posts/Medical_Product_Communications_That_Are_Consistent_With_FDA-Required_Labeling/ 2018-06-13T12:00:00-04:00 https://reguvirta.com/posts/Distribution_of_LOINC_Codes_for_In_Vitro_Diagnostic_Tests_by_Manufacturers/ 2018-06-15T12:00:00-04:00 https://reguvirta.com/posts/Medical_Device_User_Fee_Small_Business_Qualification_and_Certification_Process/ 2018-08-01T12:00:00-04:00 https://reguvirta.com/posts/Appropriate_Use_of_Voluntary_Consensus_Standards_in_Premarket_Submissions_for_Medical_Devices/ 2018-09-14T12:00:00-04:00 https://reguvirta.com/posts/Heparin_in_Medical_Devices_and_Combination_Products__Testing,_Labeling_and_Safety_Requirements/ 2018-09-20T12:00:00-04:00 https://reguvirta.com/posts/Benefit-Risk_Factors_to_Consider_When_Evaluating_Substantial_Equivalence_in_510k_Submissions/ 2018-09-25T12:00:00-04:00 https://reguvirta.com/posts/Selection_of_Package_Type_Terms_and_Discard_Statements_for_Injectable_Medical_Products/ 2018-10-03T12:00:00-04:00 https://reguvirta.com/posts/Impact_of_Revised_Common_Rule_on_FDA-Regulated_Clinical_Investigations/ 2018-10-11T12:00:00-04:00 https://reguvirta.com/posts/Manufacturing_Site_Changes_for_PMA-Approved_Medical_Devices__When_to_Submit_a_Supplement_and_Documentation_Requirements/ 2018-12-17T12:00:00-05:00 https://reguvirta.com/posts/Coordinated_Development_of_Antimicrobial_Drugs_and_Antimicrobial_Susceptibility_Test_Devices/ 2019-02-01T12:00:00-05:00 https://reguvirta.com/posts/Least_Burdensome_Principles_for_Medical_Device_Regulation/ 2019-02-05T12:00:00-05:00 https://reguvirta.com/posts/510k_Exemption_for_Unclassified_Medical_Devices_in_Selected_Product_Categories/ 2019-02-08T12:00:00-05:00 https://reguvirta.com/posts/Public_Warning_and_Notification_of_Recalls_Under_Part_7/ 2019-02-08T12:00:00-05:00 https://reguvirta.com/posts/Medical_Devices_Used_in_Recovery,_Isolation,_and_Delivery_of_Regenerative_Medicine_Advanced_Therapies/ 2019-02-15T12:00:00-05:00 https://reguvirta.com/posts/Release_of_Laboratory_Test_Results_to_Responsible_Parties_Without_Freedom_of_Information_Act_Requests/ 2019-03-01T12:00:00-05:00 https://reguvirta.com/posts/Medical_Devices_Containing_Animal-Derived_Materials_-_Safety_and_Risk_Management_Requirements/ 2019-03-15T12:00:00-04:00 https://reguvirta.com/posts/Compliance_Policy_for_Combination_Product_Postmarketing_Safety_Reporting_Requirements/ 2019-04-20T12:00:00-04:00 https://reguvirta.com/posts/Testing_and_Characterization_of_Ultra-High_Molecular_Weight_Polyethylene_(UHMWPE)_Used_in_Orthopedic_Devices/ 2019-04-26T12:00:00-04:00 https://reguvirta.com/posts/Unique_Device_Identification_Requirements_for_Convenience_Kits/ 2019-04-26T12:00:00-04:00 https://reguvirta.com/posts/Laser_Illuminated_Projectors_(LIPs)_-_Classification,_Safety_Requirements_and_Labeling/ 2019-05-08T12:00:00-04:00 https://reguvirta.com/posts/Non-Clinical_Testing_Recommendations_for_Machine_Perfusion_Devices_Used_to_Preserve_Vascularized_Human_Organs_for_Transplant/ 2019-05-08T12:00:00-04:00 https://reguvirta.com/posts/Performance_Standard_Requirements_for_Fluoroscopic_X-Ray_Systems__Timing,_Safety_Features_and_Display_Requirements/ 2019-05-08T12:00:00-04:00 https://reguvirta.com/posts/Live_Case_Presentations_During_Investigational_Device_Clinical_Trials/ 2019-07-11T12:00:00-04:00 https://reguvirta.com/posts/Technical_Specifications_for_Next_Generation_Sequencing_Data_in_Antiviral_Drug_Development/ 2019-07-18T12:00:00-04:00 https://reguvirta.com/posts/Postmarketing_Safety_Reporting_Requirements_for_Combination_Products/ 2019-07-22T12:00:00-04:00 https://reguvirta.com/posts/Metal_Expandable_Biliary_Stents_and_Associated_Delivery_Systems_-_Content_and_Testing_Requirements_for_510k_Submissions/ 2019-07-26T12:00:00-04:00 https://reguvirta.com/posts/Benefit-Risk_Assessment_with_Uncertainty_in_Medical_Device_Premarket_Submissions/ 2019-08-30T12:00:00-04:00 https://reguvirta.com/posts/Benefit-Risk_Determinations_for_Medical_Device_Premarket_Review/ 2019-08-30T12:00:00-04:00 https://reguvirta.com/posts/Humanitarian_Use_Device_(HUD)_Designation_Requests__Content_and_Format/ 2019-09-05T12:00:00-04:00 https://reguvirta.com/posts/Humanitarian_Device_Exemption_(HDE)_Program__Operational_Requirements_and_Benefit-Risk_Assessment/ 2019-09-06T12:00:00-04:00 https://reguvirta.com/posts/Special_510k_Program_for_Device_Modifications__Eligibility_Criteria_and_Submission_Requirements/ 2019-09-13T12:00:00-04:00 https://reguvirta.com/posts/The_Abbreviated_510k_Program__Using_Guidance_Documents,_Special_Controls,_and_Standards_for_Substantial_Equivalence_Demonstration/ 2019-09-13T12:00:00-04:00 https://reguvirta.com/posts/Safety_and_Performance_Based_Pathway_for_510k_Substantial_Equivalence_Demonstration/ 2019-09-20T12:00:00-04:00 https://reguvirta.com/posts/Changes_to_Medical_Device_Definition_for_Software_Functions_Under_the_21st_Century_Cures_Act/ 2019-09-27T12:00:00-04:00 https://reguvirta.com/posts/General_Wellness_Products__Policy_for_Low_Risk_Devices_and_Software_Functions/ 2019-09-27T12:00:00-04:00 https://reguvirta.com/posts/Coronary,_Peripheral,_and_Neurovascular_Guidewires_-_Performance_Testing_and_Documentation_Requirements/ 2019-10-10T12:00:00-04:00 https://reguvirta.com/posts/Labeling_for_Intravascular_Devices_with_Lubricious_Coatings/ 2019-10-10T12:00:00-04:00 https://reguvirta.com/posts/30-Day_Notice_Manufacturing_Changes_for_PMA_and_HDE_Approved_Devices/ 2019-12-16T12:00:00-05:00 https://reguvirta.com/posts/Acceptance_and_Filing_Reviews_for_Premarket_Approval_Applications_(PMAs)/ 2019-12-16T12:00:00-05:00 https://reguvirta.com/posts/Annual_Reports_for_PMA-Approved_Medical_Devices__Content,_Format_and_Submission_Requirements/ 2019-12-16T12:00:00-05:00 https://reguvirta.com/posts/Real-Time_Review_Process_for_Minor_Changes_to_Approved_Medical_Devices_through_PMA_Supplements/ 2019-12-16T12:00:00-05:00 https://reguvirta.com/posts/Bridging_Strategies_for_Drug-Device_and_Biologic-Device_Combination_Products/ 2019-12-19T12:00:00-05:00 https://reguvirta.com/posts/Recommended_Format_and_Content_for_Non-Clinical_Bench_Performance_Testing_in_Medical_Device_Premarket_Submissions/ 2019-12-20T12:00:00-05:00 https://reguvirta.com/posts/CLIA_Waiver_Applications_for_In_Vitro_Diagnostic_Devices_-_Demonstrating_Simplicity_and_Insignificant_Risk_of_Erroneous_Results/ 2020-02-26T12:00:00-05:00 https://reguvirta.com/posts/Dual_510k_and_CLIA_Waiver_by_Application_for_In_Vitro_Diagnostic_Tests/ 2020-02-26T12:00:00-05:00 https://reguvirta.com/posts/Product_Recalls,_Removals,_and_Corrections__Procedures_and_Best_Practices/ 2020-03-02T12:00:00-05:00 https://reguvirta.com/posts/Bone_Anchors_(Suture_Anchors)_for_Appendicular_Skeleton_-_Content_and_Testing_Requirements_for_510k_Submissions/ 2020-03-03T12:00:00-05:00 https://reguvirta.com/posts/Testing_and_Performance_Requirements_for_Electrosurgical_Devices_and_Accessories_for_General_Tissue_Cutting_and_Coagulation/ 2020-03-09T12:00:00-04:00 https://reguvirta.com/posts/Safety_Considerations_for_Flow_Restrictors_in_Oral_Liquid_Drug_Products_to_Prevent_Accidental_Ingestion_by_Children/ 2020-03-17T12:00:00-04:00 https://reguvirta.com/posts/Appeals_Process_and_Documentation_Requirements_for_Significant_Medical_Device_Submission_Decisions/ 2020-03-27T12:00:00-04:00 https://reguvirta.com/posts/Developing_and_Labeling_Companion_Diagnostics_for_Multiple_Oncology_Therapeutic_Products/ 2020-04-13T12:00:00-04:00 https://reguvirta.com/posts/Reliability_Requirements_for_Emergency-Use_Auto-Injectors/ 2020-04-21T12:00:00-04:00 https://reguvirta.com/posts/Requesting_Nonbinding_Feedback_on_Form_FDA_483_Inspectional_Observations/ 2020-04-22T12:00:00-04:00 https://reguvirta.com/posts/Electronic_Copy_(eCopy)_Program_for_Medical_Device_Submissions__Technical_Standards_and_Requirements/ 2020-04-27T12:00:00-04:00 https://reguvirta.com/posts/Classification_and_Special_Controls_for_Posterior_Cervical_Screw_Systems/ 2020-05-04T12:00:00-04:00 https://reguvirta.com/posts/Uniform_Inspection_Process_and_Communications_for_Medical_Device_Establishments/ 2020-06-29T12:00:00-04:00 https://reguvirta.com/posts/Clinical_Investigation_Requirements_for_Prostate_Tissue_Ablation_Systems/ 2020-07-15T12:00:00-04:00 https://reguvirta.com/posts/Electronic_Submission_Requirements_for_Medical_Device_Submissions/ 2020-07-15T12:00:00-04:00 https://reguvirta.com/posts/Multiple_Function_Device_Products__Policy_and_Considerations_for_Functions_Not_Subject_to_FDA_Review/ 2020-07-29T12:00:00-04:00 https://reguvirta.com/posts/Civil_Money_Penalties_Related_to_ClinicalTrials.gov_Requirements/ 2020-08-14T12:00:00-04:00 https://reguvirta.com/posts/Conventional_Foley_Urinary_Catheters_-_Performance_Testing_and_Labeling_Requirements/ 2020-08-14T12:00:00-04:00 https://reguvirta.com/posts/Performance_Testing_and_Safety_Requirements_for_Single-Use_Cutaneous_Recording_Electrodes/ 2020-08-14T12:00:00-04:00 https://reguvirta.com/posts/Recognition_and_Withdrawal_Process_for_Voluntary_Consensus_Standards/ 2020-09-15T12:00:00-04:00 https://reguvirta.com/posts/Accreditation_Scheme_for_Conformity_Assessment_(ASCA)_Pilot_Program_for_Medical_Device_Testing_Laboratories/ 2020-09-25T12:00:00-04:00 https://reguvirta.com/posts/Basic_Safety_and_Essential_Performance_Standards_for_Medical_Electrical_Equipment_Under_the_ASCA_Pilot_Program/ 2020-09-25T12:00:00-04:00 https://reguvirta.com/posts/Biological_Evaluation_of_Medical_Devices_Standards_in_the_Accreditation_Scheme_for_Conformity_Assessment_(ASCA)_Pilot_Program/ 2020-09-25T12:00:00-04:00 https://reguvirta.com/posts/Blood_Glucose_Monitoring_Systems_for_Prescription_Point-of-Care_Use_-_Performance_Standards_and_Technical_Requirements/ 2020-09-29T12:00:00-04:00 https://reguvirta.com/posts/Breast_Implant_Labeling__Patient_Communication_and_Risk_Information_Requirements/ 2020-09-29T12:00:00-04:00 https://reguvirta.com/posts/Breast_Implants_-_Premarket_Requirements_for_Saline_and_Silicone_Gel-Filled_Devices/ 2020-09-29T12:00:00-04:00 https://reguvirta.com/posts/Self-Monitoring_Blood_Glucose_Test_Systems_for_Over-the-Counter_Home_Use/ 2020-09-29T12:00:00-04:00 https://reguvirta.com/posts/Testing_for_Biotin_Interference_in_In_Vitro_Diagnostic_Devices_Using_Biotin_Avidin_Technology/ 2020-10-16T12:00:00-04:00 https://reguvirta.com/posts/Regulatory_Considerations_for_Microneedling_Devices_Used_in_Aesthetic_Skin_Treatments/ 2020-11-10T12:00:00-05:00 https://reguvirta.com/posts/Certificates_of_Confidentiality_for_Non-Federally_Funded_Research__Protection_of_Human_Subject_Privacy_in_FDA-Regulated_Studies/ 2020-11-13T12:00:00-05:00 https://reguvirta.com/posts/Obtaining_FDA_Feedback_for_Combination_Products__Best_Practices_and_Meeting_Procedures/ 2020-12-04T12:00:00-05:00 https://reguvirta.com/posts/Spinal_Plating_Systems_-_Safety_and_Performance_Based_Testing_for_Anterior_Cervical_and_Anterior_Lateral_Thoracolumbar_Devices/ 2020-12-11T12:00:00-05:00 https://reguvirta.com/posts/Testing_and_Performance_Requirements_for_MR_Receive-Only_Coils_for_General_Diagnostic_Use/ 2020-12-11T12:00:00-05:00 https://reguvirta.com/posts/Product_Labeling_Requirements_for_Laparoscopic_Power_Morcellators_in_Gynecologic_Surgery/ 2020-12-30T12:00:00-05:00 https://reguvirta.com/posts/Mouse_Embryo_Assay_Testing_for_Assisted_Reproduction_Technology_Devices/ 2021-01-05T12:00:00-05:00 https://reguvirta.com/posts/Safer_Technologies_Program_for_Medical_Devices_and_Device-Led_Combination_Products_with_Enhanced_Safety_Benefits/ 2021-01-06T12:00:00-05:00 https://reguvirta.com/posts/Implanted_Brain-Computer_Interface_(BCI)_Devices_for_Patients_with_Paralysis_or_Amputation_-_Technical_Considerations_for_Q-Submissions_and_IDE_Applications/ 2021-05-20T12:00:00-04:00 https://reguvirta.com/posts/Implementation_of_ICH_Q12_Tools_and_Enablers_for_Post-Approval_CMC_Changes_in_Drug_Products_and_Combination_Products/ 2021-05-20T12:00:00-04:00 https://reguvirta.com/posts/Peripheral_Vascular_Atherectomy_Devices_-_Content_and_Testing_Requirements_for_510k_Submissions/ 2021-05-20T12:00:00-04:00 https://reguvirta.com/posts/In_Vitro_Testing_and_Labeling_for_Oral_Drug_Products_Administered_via_Enteral_Feeding_Tubes/ 2021-06-02T12:00:00-04:00 https://reguvirta.com/posts/Unique_Device_Identifier_(UDI)_Form_and_Content_Requirements/ 2021-07-07T12:00:00-04:00 https://reguvirta.com/posts/Technical_Considerations_for_Nitinol-Containing_Medical_Devices/ 2021-07-09T12:00:00-04:00 https://reguvirta.com/posts/Export_Certification_Process_and_Requirements_for_FDA-Regulated_Products/ 2021-08-20T12:00:00-04:00 https://reguvirta.com/posts/Safety_Reporting_Requirements_for_Clinical_Investigators_in_IND_and_IDE_Studies/ 2021-09-29T12:00:00-04:00 https://reguvirta.com/posts/Acceptance_Review_for_De_Novo_Classification_Requests/ 2021-10-05T12:00:00-04:00 https://reguvirta.com/posts/De_Novo_Classification_Process_for_Novel_Medical_Devices_Without_Predicates/ 2021-10-05T12:00:00-04:00 https://reguvirta.com/posts/Labeling_Requirements_for_Surgical_Staplers_and_Staples_for_Internal_Use/ 2021-10-08T12:00:00-04:00 https://reguvirta.com/posts/Multiple_Patient_Use_Arthroscopy_Pump_Tubing_Sets_-_Safety,_Testing_and_Labeling_Requirements/ 2021-12-23T12:00:00-05:00 https://reguvirta.com/posts/Clinical_and_Non-Clinical_Testing_for_Medical_Devices_to_Treat_Benign_Prostatic_Hyperplasia_(BPH)/ 2021-12-27T12:00:00-05:00 https://reguvirta.com/posts/Histopathology_Peer_Review_in_Nonclinical_Toxicology_Studies/ 2021-12-27T12:00:00-05:00 https://reguvirta.com/posts/Patient-Reported_Outcome_Instruments_in_Medical_Device_Evaluation/ 2022-01-26T12:00:00-05:00 https://reguvirta.com/posts/Patient_Engagement_in_Medical_Device_Clinical_Studies__Roles,_Benefits_and_Best_Practices/ 2022-01-26T12:00:00-05:00 https://reguvirta.com/posts/Premarket_Review_Pathways_for_Combination_Products/ 2022-01-26T12:00:00-05:00 https://reguvirta.com/posts/Including_Older_Adults_in_Cancer_Clinical_Trials__Design_and_Conduct_Considerations/ 2022-03-02T12:00:00-05:00 https://reguvirta.com/posts/Procedures_for_Supervisory_Review,_Appeals,_and_Dispute_Resolution_for_Medical_Device_Decisions/ 2022-03-02T12:00:00-05:00 https://reguvirta.com/posts/Compliance_Requirements_for_Ophthalmic_Drug-Device_Combination_Products_Following_Genus_Decision/ 2022-03-22T12:00:00-04:00 https://reguvirta.com/posts/Non-Spinal_Metallic_Fracture_Fixation_Plates_-_Safety_and_Performance_Based_Testing_Requirements/ 2022-04-11T12:00:00-04:00 https://reguvirta.com/posts/Testing_and_Performance_Requirements_for_Surgical_Sutures/ 2022-04-11T12:00:00-04:00 https://reguvirta.com/posts/Facet_Screw_Systems_-_Safety_and_Performance_Based_Pathway/ 2022-04-13T12:00:00-04:00 https://reguvirta.com/posts/Testing_and_Safety_Requirements_for_Denture_Base_Resins/ 2022-04-13T12:00:00-04:00 https://reguvirta.com/posts/Refuse_to_Accept_Policy_for_510k_Submissions__Minimum_Threshold_Requirements_for_Administrative_and_Technical_Review/ 2022-04-21T12:00:00-04:00 https://reguvirta.com/posts/Clinical_Studies_for_Medical_Devices_Treating_Type_2_Diabetes_Through_Novel_Therapeutic_Approaches/ 2022-05-06T12:00:00-04:00 https://reguvirta.com/posts/Electromagnetic_Compatibility_for_Medical_Devices_and_Accessories__Testing,_Documentation,_and_Labeling_Requirements/ 2022-06-06T12:00:00-04:00 https://reguvirta.com/posts/Technical_Performance_Assessment_of_Quantitative_Imaging_in_Radiological_Devices/ 2022-06-16T12:00:00-04:00 https://reguvirta.com/posts/Unique_Device_Identification_Policy_for_Class_I_and_Unclassified_Devices__Compliance_Dates_and_Requirements/ 2022-07-25T12:00:00-04:00 https://reguvirta.com/posts/Patient_Labeling_for_Laser-Assisted_In_Situ_Keratomileusis_(LASIK)_Devices/ 2022-07-28T12:00:00-04:00 https://reguvirta.com/posts/Applying_Previously_Cleared_IVD_Assays_to_Additional_Automated_Laboratory_Instruments/ 2022-08-17T12:00:00-04:00 https://reguvirta.com/posts/Regulatory_Requirements_for_Hearing_Aids_and_Personal_Sound_Amplification_Products_(PSAPs)/ 2022-08-17T12:00:00-04:00 https://reguvirta.com/posts/Policy_for_Monkeypox_Testing_During_the_Public_Health_Emergency/ 2022-09-07T12:00:00-04:00 https://reguvirta.com/posts/Computer_Software_Assurance_for_Production_and_Quality_System_Software/ 2022-09-13T12:00:00-04:00 https://reguvirta.com/posts/Ethical_Considerations_for_Clinical_Investigations_of_Medical_Products_in_Children/ 2022-09-26T12:00:00-04:00 https://reguvirta.com/posts/Clinical_Decision_Support_Software_Functions__Device_vs_Non-Device_Classification/ 2022-09-28T12:00:00-04:00 https://reguvirta.com/posts/Clinical_Performance_Assessment_of_Computer-Assisted_Detection_Devices_in_Radiology/ 2022-09-28T12:00:00-04:00 https://reguvirta.com/posts/Computer-Assisted_Detection_Devices_in_Radiology__Performance_Testing,_Documentation_and_Labeling_Requirements/ 2022-09-28T12:00:00-04:00 https://reguvirta.com/posts/Medical_Device_Data_Systems,_Medical_Image_Storage,_and_Medical_Image_Communications_Devices_-_Policy_for_Functionality_and_Regulatory_Status/ 2022-09-28T12:00:00-04:00 https://reguvirta.com/posts/Policy_for_Device_Software_Functions_and_Mobile_Medical_Applications/ 2022-09-28T12:00:00-04:00 https://reguvirta.com/posts/Technical_Performance_Assessment_and_Premarket_Requirements_for_Digital_Diagnostic_Radiology_Display_Devices/ 2022-09-28T12:00:00-04:00 https://reguvirta.com/posts/De_Novo_Classification_Request_Review_Process_and_Performance_Goals/ 2022-10-03T12:00:00-04:00 https://reguvirta.com/posts/FDA_Actions_on_Premarket_Approval_Applications_(PMAs)_and_Effects_on_MDUFA_Review_Goals_and_Timelines/ 2022-10-03T12:00:00-04:00 https://reguvirta.com/posts/MDUFA_Performance_Goals_and_Processing_of_510k_Submissions/ 2022-10-03T12:00:00-04:00 https://reguvirta.com/posts/De_Novo_Classification_Request_User_Fees_and_Refund_Policies/ 2022-10-05T12:00:00-04:00 https://reguvirta.com/posts/User_Fee_Requirements_and_Payment_Process_for_513(g)_Requests_for_Information/ 2022-10-05T12:00:00-04:00 https://reguvirta.com/posts/User_Fees_and_Refunds_for_510k_Submissions/ 2022-10-05T12:00:00-04:00 https://reguvirta.com/posts/User_Fees_and_Refunds_for_Premarket_Approval_Applications_and_Biologics_License_Applications/ 2022-10-05T12:00:00-04:00 https://reguvirta.com/posts/Post-Approval_Studies_for_Medical_Devices__Protocol_Development,_Tracking_and_Reporting_Requirements/ 2022-10-07T12:00:00-04:00 https://reguvirta.com/posts/Postmarket_Surveillance_Studies_Requirements_for_Medical_Devices_Under_Section_522/ 2022-10-07T12:00:00-04:00 https://reguvirta.com/posts/Developing_and_Responding_to_Medical_Device_Marketing_Application_Deficiencies/ 2022-10-26T12:00:00-04:00 https://reguvirta.com/posts/References_to_Section_201(h)_of_the_FD&C_Act_Following_the_Safeguarding_Therapeutics_Act/ 2022-11-14T12:00:00-05:00 https://reguvirta.com/posts/Clinical_Investigator_Disqualification_Procedures_and_Administrative_Actions/ 2022-12-01T12:00:00-05:00 https://reguvirta.com/posts/Human_Factors_Information_Needed_in_Medical_Device_Marketing_Submissions/ 2022-12-09T12:00:00-05:00 https://reguvirta.com/posts/COVID-19_Testing_Policy__Validation_Requirements_and_Recommendations_for_Diagnostic_and_Serology_Tests/ 2023-01-12T12:00:00-05:00 https://reguvirta.com/posts/Impact_of_Viral_Mutations_on_SARS-CoV-2_Tests__Evaluation_and_Monitoring_Recommendations/ 2023-01-12T12:00:00-05:00 https://reguvirta.com/posts/Technical_Considerations_for_Photobiomodulation_Devices_in_510k_Submissions/ 2023-01-12T12:00:00-05:00 https://reguvirta.com/posts/Assembly_and_Installation_Requirements_for_Diagnostic_X-ray_Equipment_and_Components/ 2023-02-21T12:00:00-05:00 https://reguvirta.com/posts/Harmonization_of_Performance_Standards_for_Diagnostic_X-Ray_Imaging_Systems_and_Components_with_IEC_Standards/ 2023-02-21T12:00:00-05:00 https://reguvirta.com/posts/Laser_Products_-_Conformance_with_IEC_60825-1_Ed._3_and_IEC_60601-2-22_Ed._3.1_Standards/ 2023-02-21T12:00:00-05:00 https://reguvirta.com/posts/Marketing_Clearance_Requirements_for_Diagnostic_Ultrasound_Systems_and_Transducers/ 2023-02-21T12:00:00-05:00 https://reguvirta.com/posts/Performance_Standards_for_Diagnostic_X-Ray_Systems_and_Major_Components/ 2023-02-21T12:00:00-05:00 https://reguvirta.com/posts/Ultrasonic_Diathermy_(Physiotherapy)_Devices_-_Technical_and_Safety_Requirements_for_510k_Submissions/ 2023-02-21T12:00:00-05:00 https://reguvirta.com/posts/Transition_Plan_for_Medical_Devices_Distributed_Under_COVID-19_Emergency_Enforcement_Policies/ 2023-03-27T12:00:00-04:00 https://reguvirta.com/posts/Transition_Plan_for_Medical_Devices_with_COVID-19_Emergency_Use_Authorization_After_Declaration_Termination/ 2023-03-27T12:00:00-04:00 https://reguvirta.com/posts/Animal_Testing_for_Medical_Device_Safety_and_Performance_Evaluation/ 2023-03-28T12:00:00-04:00 https://reguvirta.com/posts/Testing_and_Performance_Requirements_for_Soft_Daily_Wear_Contact_Lenses/ 2023-03-28T12:00:00-04:00 https://reguvirta.com/posts/Process_for_Research_Involving_Children_that_Requires_FDA_and_OHRP_Review_under_21_CFR_50.54_and_45_CFR_46.407/ 2023-03-30T12:00:00-04:00 https://reguvirta.com/posts/Risk-Based_Monitoring_of_Clinical_Investigations/ 2023-04-12T12:00:00-04:00 https://reguvirta.com/posts/Testing_Considerations_for_Percutaneous_Transluminal_Angioplasty_(PTA)_and_Specialty_Balloon_Catheters/ 2023-04-14T12:00:00-04:00 https://reguvirta.com/posts/Use_of_Whole_Slide_Imaging_in_GLP_Nonclinical_Toxicology_Studies/ 2023-05-24T12:00:00-04:00 https://reguvirta.com/posts/Testing_of_Tissue_Containment_Systems_Used_During_Power_Morcellation_Procedures/ 2023-05-26T12:00:00-04:00 https://reguvirta.com/posts/Requests_for_Feedback_and_Meetings_for_Medical_Device_Submissions__The_Q-Submission_Program/ 2023-06-02T12:00:00-04:00 https://reguvirta.com/posts/Content_of_Premarket_Submissions_for_Device_Software_Functions/ 2023-06-14T12:00:00-04:00 https://reguvirta.com/posts/Patient-Matched_Orthopedic_Surgical_Guides__Testing,_Documentation_and_Safety_Requirements/ 2023-06-28T12:00:00-04:00 https://reguvirta.com/posts/Medical_Device_Development_Tools_(MDDT)_Qualification_Program/ 2023-07-17T12:00:00-04:00 https://reguvirta.com/posts/Labeling_Recommendations_for_Hydrogen_Peroxide-Based_Contact_Lens_Care_Products/ 2023-07-27T12:00:00-04:00 https://reguvirta.com/posts/Off-The-Shelf_Software_in_Medical_Devices__Documentation_Requirements_for_Premarket_Submissions/ 2023-08-11T12:00:00-04:00 https://reguvirta.com/posts/Informed_Consent_in_Clinical_Investigations__Requirements,_Documentation,_and_Procedures/ 2023-08-15T12:00:00-04:00 https://reguvirta.com/posts/Face_Masks_and_Barrier_Face_Coverings_for_Medical_Purposes_During_the_COVID-19_Public_Health_Emergency/ 2023-09-05T12:00:00-04:00 https://reguvirta.com/posts/Best_Practices_for_Selecting_Predicate_Devices_in_510k_Submissions/ 2023-09-07T12:00:00-04:00 https://reguvirta.com/posts/Human_Factors_Studies_and_Related_Analyses_for_Combination_Products/ 2023-09-07T12:00:00-04:00 https://reguvirta.com/posts/Technical_Considerations_for_Long-Term_Implantable_Medical_Devices_Requiring_510k/ 2023-09-07T12:00:00-04:00 https://reguvirta.com/posts/When_Clinical_Data_is_Needed_to_Support_Substantial_Equivalence_for_510k_Submissions/ 2023-09-07T12:00:00-04:00 https://reguvirta.com/posts/Use_of_ISO_10993-1_for_Biological_Evaluation_and_Testing_of_Medical_Devices/ 2023-09-08T12:00:00-04:00 https://reguvirta.com/posts/Breakthrough_Devices_Program__Expedited_Development_and_Review_Process_for_Novel_Medical_Devices/ 2023-09-14T12:00:00-04:00 https://reguvirta.com/posts/Clinical_Study_Design_and_Benefit-Risk_Considerations_for_Weight_Loss_Medical_Devices/ 2023-09-15T12:00:00-04:00 https://reguvirta.com/posts/Non-Clinical_Testing_Recommendations_for_Weight_Loss_and_Obesity_Treatment_Devices/ 2023-09-15T12:00:00-04:00 https://reguvirta.com/posts/Voluntary_Improvement_Program_(VIP)_for_Medical_Device_Manufacturers__Participation_Requirements_and_Implementation/ 2023-09-15T12:00:00-04:00 https://reguvirta.com/posts/Cybersecurity_in_Medical_Devices__Design,_Implementation,_and_Premarket_Submissions/ 2023-09-27T12:00:00-04:00 https://reguvirta.com/posts/Development_of_Products_for_Prevention_and_Treatment_of_Acute_and_Chronic_Graft-Versus-Host_Disease/ 2023-09-28T12:00:00-04:00 https://reguvirta.com/posts/Predetermined_Change_Control_Plans_for_Antimicrobial_Susceptibility_Test_Systems__Updating_Breakpoints_in_Device_Labeling/ 2023-09-29T12:00:00-04:00 https://reguvirta.com/posts/Technical_Considerations_for_Physiologic_Closed-Loop_Control_Medical_Devices/ 2023-09-29T12:00:00-04:00 https://reguvirta.com/posts/Electronic_Submission_Template_And_Resource_(eSTAR)_for_510k_Submissions/ 2023-10-02T12:00:00-04:00 https://reguvirta.com/posts/Premarket_Notification_Requirements_for_Magnetic_Resonance_Diagnostic_Devices/ 2023-10-10T12:00:00-04:00 https://reguvirta.com/posts/Testing_and_Labeling_of_Medical_Devices_for_Magnetic_Resonance_(MR)_Environment_Safety_and_Compatibility/ 2023-10-10T12:00:00-04:00 https://reguvirta.com/posts/Modifications_to_Non-Invasive_Remote_Monitoring_Devices_for_Patient_Monitoring_During_Public_Health_Emergencies/ 2023-10-19T12:00:00-04:00 https://reguvirta.com/posts/Manufacturing_and_Supply_Chain_Changes_for_PMA_and_HDE_Devices_During_Public_Health_Emergency/ 2023-11-02T12:00:00-04:00 https://reguvirta.com/posts/Clinical_Electronic_Thermometers_-_Performance,_Safety,_and_Regulatory_Requirements/ 2023-11-03T12:00:00-04:00 https://reguvirta.com/posts/Review_Process_for_Denied_Export_Certificates_for_Medical_Devices/ 2023-11-03T12:00:00-04:00 https://reguvirta.com/posts/Assessing_the_Credibility_of_Computational_Modeling_and_Simulation_in_Medical_Device_Submissions/ 2023-11-17T12:00:00-05:00 https://reguvirta.com/posts/Translation_of_Non-English_Good_Laboratory_Practice_(GLP)_Study_Reports/ 2023-11-21T12:00:00-05:00 https://reguvirta.com/posts/Use_of_Real-World_Data_and_Real-World_Evidence_to_Support_Medical_Device_Regulatory_Decision-Making/ 2023-12-14T12:00:00-05:00 https://reguvirta.com/posts/Submission_Requirements_for_Terminally_Sterilized_Medical_Devices/ 2024-01-08T12:00:00-05:00 https://reguvirta.com/posts/Orthopedic_Device_Metallic_and_Calcium_Phosphate_Coatings__Testing_and_Characterization_Requirements/ 2024-01-23T12:00:00-05:00 https://reguvirta.com/posts/Remote_Regulatory_Assessments_for_FDA-Regulated_Products_and_Establishments/ 2024-02-02T12:00:00-05:00 https://reguvirta.com/posts/Medical_Device_User_Fee_Small_Business_Qualification_and_Financial_Hardship_Waivers/ 2024-02-22T12:00:00-05:00 https://reguvirta.com/posts/Cybersecurity_Requirements_for_Connected_Medical_Devices_with_Software/ 2024-03-13T12:00:00-04:00 https://reguvirta.com/posts/Evaluation_of_Thermal_Effects_from_Medical_Devices_on_Human_Tissue/ 2024-03-15T12:00:00-04:00 https://reguvirta.com/posts/Q-Submission_Program_for_Medical_Device_Manufacturer_Feedback_and_FDA_Meetings/ 2024-03-15T12:00:00-04:00 https://reguvirta.com/posts/Animal_Testing_Recommendations_for_Dental_Bone_Grafting_Materials/ 2024-03-29T12:00:00-04:00 https://reguvirta.com/posts/Enforcement_Policies_for_Unauthorized_Diagnostic_Tests_During_Public_Health_Emergencies/ 2024-05-06T12:00:00-04:00 https://reguvirta.com/posts/Policy_for_Laboratory_Tests_Used_in_Response_to_Chemical,_Biological,_Radiological,_or_Nuclear_Public_Health_Emergencies/ 2024-05-06T12:00:00-04:00 https://reguvirta.com/posts/Distinguishing_Between_Medical_Device_Servicing_and_Remanufacturing_Activities/ 2024-05-10T12:00:00-04:00 https://reguvirta.com/posts/Bioresearch_Monitoring_Program_Inspections__Processes_and_Procedures_for_Site_Evaluations/ 2024-06-05T12:00:00-04:00 https://reguvirta.com/posts/Circumstances_that_Constitute_Delaying,_Denying,_Limiting,_or_Refusing_a_Drug_or_Device_Inspection/ 2024-06-20T12:00:00-04:00 https://reguvirta.com/posts/Laboratory_Developed_Tests_(LDTs)_Enforcement_Discretion_Policy_and_Phased_Compliance_Requirements/ 2024-06-25T12:00:00-04:00 https://reguvirta.com/posts/Essential_Drug_Delivery_Outputs_for_Drug_Delivery_Devices_and_Combination_Products/ 2024-06-28T12:00:00-04:00 https://reguvirta.com/posts/Use-Related_Risk_Analysis_for_Drug,_Biological,_and_Combination_Products__Determining_Human_Factors_Study_Needs/ 2024-07-08T12:00:00-04:00 https://reguvirta.com/posts/Clinical_Study_Design_Recommendations_for_Devices_to_Treat_Opioid_Use_Disorder/ 2024-07-11T12:00:00-04:00 https://reguvirta.com/posts/Premarket_Notification_Requirements_for_Dental_Composite_Resin_Devices/ 2024-07-12T12:00:00-04:00 https://reguvirta.com/posts/Premarket_Notification_Requirements_for_Dental_Curing_Light_Devices/ 2024-07-12T12:00:00-04:00 https://reguvirta.com/posts/User_Fees_for_Combination_Products_and_Associated_Waivers/ 2024-07-16T12:00:00-04:00 https://reguvirta.com/posts/Electronic_Submission_of_User_Manuals_and_Radiation_Safety_Reports_for_Electronic_Products/ 2024-08-19T12:00:00-04:00 https://reguvirta.com/posts/Predetermined_Change_Control_Plans_for_Medical_Device_Modifications/ 2024-08-22T12:00:00-04:00 https://reguvirta.com/posts/Device_Classification_and_Regulatory_Requirements__Procedures_for_513(g)_Requests_for_Information/ 2024-08-23T12:00:00-04:00 https://reguvirta.com/posts/Electronic_Submission_Template_And_Resource_(eSTAR)_for_De_Novo_Classification_Requests/ 2024-08-23T12:00:00-04:00 https://reguvirta.com/posts/Mammography_Quality_Standards__Requirements_for_Facilities,_Personnel,_Equipment,_and_Reporting/ 2024-08-26T12:00:00-04:00 https://reguvirta.com/posts/Voluntary_Malfunction_Summary_Reporting_Program_for_Medical_Devices/ 2024-08-29T12:00:00-04:00 https://reguvirta.com/posts/Patient_Preference_Information_in_Medical_Device_Development_and_Benefit-Risk_Assessments/ 2024-09-06T12:00:00-04:00 https://reguvirta.com/posts/Appeals_Process_for_Mammography_Facilities_under_MQSA__Adverse_Accreditation_Decisions,_Certificate_Actions,_and_Patient_Notifications/ 2024-09-10T12:00:00-04:00 https://reguvirta.com/posts/Chemical_Analysis_in_Medical_Device_Biocompatibility_Assessment/ 2024-09-20T12:00:00-04:00 https://reguvirta.com/posts/Basic_Safety_and_Essential_Performance_Standards_in_the_Accreditation_Scheme_for_Conformity_Assessment_(ASCA)_Program/ 2024-09-23T12:00:00-04:00 https://reguvirta.com/posts/Biocompatibility_Testing_Standards_and_Accreditation_Requirements_in_the_ASCA_Program/ 2024-09-23T12:00:00-04:00 https://reguvirta.com/posts/The_Accreditation_Scheme_for_Conformity_Assessment_(ASCA)_Program_for_Medical_Device_Testing_Laboratories/ 2024-09-23T12:00:00-04:00 https://reguvirta.com/posts/X-Ray_Equipment_Performance_Standards_and_Radiation_Safety_Requirements/ 2024-09-27T12:00:00-04:00 https://reguvirta.com/posts/Air-Powered_Dental_Handpieces_and_Motors_-_Performance_Testing_and_Safety_Requirements/ 2024-09-30T12:00:00-04:00 https://reguvirta.com/posts/Dental_Impression_Materials__Performance_Criteria_and_Testing_Requirements/ 2024-09-30T12:00:00-04:00 https://reguvirta.com/posts/Technical_Considerations_for_Dental_Ceramics_Used_in_Artificial_Teeth_and_Restorations/ 2024-09-30T12:00:00-04:00 https://reguvirta.com/posts/Technical_Performance_Testing_for_Dental_Cements_and_Resin-Modified_Materials/ 2024-09-30T12:00:00-04:00 https://reguvirta.com/posts/Testing_and_Labeling_Requirements_for_Titanium_Alloy_Dental_Implants_and_Abutments/ 2024-10-15T12:00:00-04:00 https://reguvirta.com/posts/Long-Term_Neurodevelopmental_Safety_Evaluation_of_Medical_Products_Used_in_Neonates/ 2024-10-17T12:00:00-04:00 https://reguvirta.com/posts/Third_Party_Review_Program_for_Medical_Device_510k_and_Emergency_Use_Authorization_Reviews/ 2024-11-21T12:00:00-05:00 https://reguvirta.com/posts/Class_II_Non-Spinal_Metallic_Bone_Screws_and_Washers_-_Safety_and_Performance_Based_Pathway/ 2024-11-22T12:00:00-05:00 https://reguvirta.com/posts/Technical_Considerations_for_Non-Spinal_Metallic_and_Polymer_Bone_Plates_and_Screws/ 2024-11-22T12:00:00-05:00 https://reguvirta.com/posts/Ethylene_Oxide_Sterilization_Facility_Changes_for_Class_III_Medical_Devices_During_EPA_Emissions_Standards_Transition/ 2024-11-26T12:00:00-05:00 https://reguvirta.com/posts/Predetermined_Change_Control_Plans_for_Artificial_Intelligence_and_Machine_Learning-Enabled_Device_Software_Functions/ 2024-12-04T12:00:00-05:00 https://reguvirta.com/posts/Global_Unique_Device_Identification_Database_(GUDID)_Data_Submission_and_Management_Requirements/ 2024-12-17T12:00:00-05:00 https://reguvirta.com/posts/Validation_of_In_Vitro_Diagnostic_Tests_for_Emerging_Pathogens_During_Public_Health_Emergencies/ 2025-01-06T12:00:00-05:00 https://reguvirta.com/posts/Content_of_Premarket_Submissions_and_Lifecycle_Management_for_Artificial_Intelligence_and_Machine_Learning-Enabled_Medical_Devices/ 2025-01-07T12:00:00-05:00 https://reguvirta.com/posts/Notifying_Device_Supply_Disruptions_and_Manufacturing_Discontinuances_During_Public_Health_Emergencies/ 2025-01-07T12:00:00-05:00 https://reguvirta.com/posts/Performance_Testing_and_Labeling_Requirements_for_Pulse_Oximeters_with_Focus_on_Accuracy_Across_Skin_Pigmentation/ 2025-01-07T12:00:00-05:00 https://reguvirta.com/posts/Modular_Submissions_for_Premarket_Approval_Applications_and_Humanitarian_Device_Exemptions/ 2025-01-13T12:00:00-05:00 https://reguvirta.com/posts/Written_Procedures_for_Institutional_Review_Boards_(IRBs)__Content_and_Organization/ 2025-02-05T12:00:00-05:00 https://reguvirta.com/posts/Evaluation_of_Sex-Specific_Data_in_Medical_Device_Clinical_Studies/ 2025-03-31T12:00:00-04:00 https://reguvirta.com/posts/Electronic_Submission_Standards_for_Pre-Submissions_Using_eSTAR_Template_System/ 2025-05-29T12:00:00-04:00 https://reguvirta.com/posts/Q-Submission_Program__Strategic_Framework_for_FDA_Interactions_in_Medical_Device_Development/ 2025-05-29T12:00:00-04:00 https://reguvirta.com/knowledge-base/ 2026-02-02T06:56:22-05:00 https://reguvirta.com/stay-informed/ 2026-02-02T06:56:22-05:00 https://reguvirta.com/tags/ 2026-02-02T06:56:22-05:00 https://reguvirta.com/categories/ 2026-02-02T06:56:22-05:00 https://reguvirta.com/about/ 2026-02-02T06:56:22-05:00 https://reguvirta.com/ https://reguvirta.com/tags/medical-devices/ https://reguvirta.com/tags/radiation-emitting-products/ https://reguvirta.com/tags/radiological-health/ https://reguvirta.com/tags/laser-notice/ https://reguvirta.com/tags/premarket/ https://reguvirta.com/tags/clinical-trials/ https://reguvirta.com/tags/food-beverages/ https://reguvirta.com/tags/investigational-new-drug-application-inda/ https://reguvirta.com/tags/pharmacology-toxicology/ https://reguvirta.com/tags/drugs/ https://reguvirta.com/tags/animal-veterinary/ https://reguvirta.com/tags/compliance/ https://reguvirta.com/tags/food-color-additives/ https://reguvirta.com/tags/biologics/ https://reguvirta.com/tags/radiology/ https://reguvirta.com/tags/investigation-enforcement/ https://reguvirta.com/tags/tanning-lamps/ https://reguvirta.com/tags/booths-beds/ https://reguvirta.com/tags/510-k/ https://reguvirta.com/tags/tobacco/ https://reguvirta.com/tags/dietary-supplements/ https://reguvirta.com/tags/cosmetics/ https://reguvirta.com/tags/gastroenterology-urology/ https://reguvirta.com/tags/labeling/ https://reguvirta.com/tags/laboratory-tests/ https://reguvirta.com/tags/ivds-in-vitro-diagnostic-devices/ https://reguvirta.com/tags/postmarket/ https://reguvirta.com/tags/antimicrobial-resistance/ https://reguvirta.com/tags/investigational-device-exemption-ide/ https://reguvirta.com/tags/adverse-event-reporting-system-faers/ https://reguvirta.com/tags/good-clinical-practice-gcp/ https://reguvirta.com/tags/administrative-procedural/ https://reguvirta.com/tags/advertising/ https://reguvirta.com/tags/premarket-approval-pma/ https://reguvirta.com/tags/pediatric-product-development/ https://reguvirta.com/tags/cardiovascular/ https://reguvirta.com/tags/digital-health/ https://reguvirta.com/tags/advisory-committees/ https://reguvirta.com/tags/electronic-submissions/ https://reguvirta.com/tags/current-good-manufacturing-practice-cgmp/ https://reguvirta.com/tags/combination-products/ https://reguvirta.com/tags/user-fees/ https://reguvirta.com/tags/dental/ https://reguvirta.com/tags/clinical-medical/ https://reguvirta.com/tags/biostatistics/ https://reguvirta.com/tags/orthopedic/ https://reguvirta.com/tags/ophthalmic/ https://reguvirta.com/tags/adverse-event-reporting/ https://reguvirta.com/tags/records/ https://reguvirta.com/tags/udi/ https://reguvirta.com/tags/immunology-microbiology/ https://reguvirta.com/tags/molecular-and-clinical-genetics/ https://reguvirta.com/tags/ebola/ https://reguvirta.com/tags/physical-medicine/ https://reguvirta.com/tags/errors/ https://reguvirta.com/tags/clinical-chemistry-clinical-toxicology/ https://reguvirta.com/tags/nose-throat/ https://reguvirta.com/tags/hematology-pathology/ https://reguvirta.com/tags/ear/ https://reguvirta.com/tags/safety-issues/ https://reguvirta.com/tags/obstetrical-gynecological/ https://reguvirta.com/tags/general-hospital-personal-use/ https://reguvirta.com/tags/general-plastic-surgery/ https://reguvirta.com/tags/anesthesiology/ https://reguvirta.com/tags/and-problems/ https://reguvirta.com/tags/neurological/ https://reguvirta.com/tags/hud-hde/ https://reguvirta.com/tags/emergencies/ https://reguvirta.com/tags/recalls/ https://reguvirta.com/tags/pharmaceutical-quality/ https://reguvirta.com/tags/compounding/ https://reguvirta.com/tags/real-world-data-real-world-evidence-rwd-rwe/ https://reguvirta.com/tags/microbiology/ https://reguvirta.com/tags/clia-clinical-laboratory-improvement-amendments/ https://reguvirta.com/tags/biotechnology/ https://reguvirta.com/tags/tissue/ https://reguvirta.com/tags/international/ https://reguvirta.com/tags/chemistry/ https://reguvirta.com/tags/manufacturing/ https://reguvirta.com/tags/and-controls-cmc/ https://reguvirta.com/tags/testing/ https://reguvirta.com/tags/gene-therapy/ https://reguvirta.com/tags/clinical-antimicrobial/ https://reguvirta.com/tags/device-drug-safety/ https://reguvirta.com/tags/over-the-counter-drugs/ https://reguvirta.com/tags/blood/ https://reguvirta.com/tags/blood-products/ https://reguvirta.com/tags/research/ https://reguvirta.com/tags/animal-cell-based-products/ https://reguvirta.com/tags/export/ https://reguvirta.com/tags/import/ https://reguvirta.com/tags/coronavirus/ https://reguvirta.com/tags/inspection/ https://reguvirta.com/tags/regulation/ https://reguvirta.com/tags/administration/ https://reguvirta.com/tags/outbreak/ https://reguvirta.com/tags/biopharmaceutics/ https://reguvirta.com/tags/bioequivalence/ https://reguvirta.com/tags/generic-drugs/ https://reguvirta.com/tags/investigational-new-animal-drug-inad/ https://reguvirta.com/tags/biosimilars/ https://reguvirta.com/tags/vaccines/ https://reguvirta.com/tags/new-animal-drug-application-nada/ https://reguvirta.com/tags/gudid/ https://reguvirta.com/categories/fda-guidance/ https://reguvirta.com/categories/final/ https://reguvirta.com/categories/draft/