Premarket 313
- Evaluation of Sex-Specific Data in Medical Device Clinical Studies
- Modular Submissions for Premarket Approval Applications and Humanitarian Device Exemptions
- Performance Testing and Labeling Requirements for Pulse Oximeters with Focus on Accuracy Across Skin Pigmentation (DRAFT)
- Content of Premarket Submissions and Lifecycle Management for Artificial Intelligence and Machine Learning-Enabled Medical Devices (DRAFT)
- Predetermined Change Control Plans for Artificial Intelligence and Machine Learning-Enabled Device Software Functions
- Technical Considerations for Non-Spinal Metallic and Polymer Bone Plates and Screws
- Class II Non-Spinal Metallic Bone Screws and Washers - Safety and Performance Based Pathway
- Third Party Review Program for Medical Device 510k and Emergency Use Authorization Reviews
- Testing and Labeling Requirements for Titanium Alloy Dental Implants and Abutments
- Technical Performance Testing for Dental Cements and Resin-Modified Materials
- Technical Considerations for Dental Ceramics Used in Artificial Teeth and Restorations
- Dental Impression Materials: Performance Criteria and Testing Requirements
- Air-Powered Dental Handpieces and Motors - Performance Testing and Safety Requirements
- The Accreditation Scheme for Conformity Assessment (ASCA) Program for Medical Device Testing Laboratories (DRAFT)
- Biocompatibility Testing Standards and Accreditation Requirements in the ASCA Program (DRAFT)
- Basic Safety and Essential Performance Standards in the Accreditation Scheme for Conformity Assessment (ASCA) Program (DRAFT)
- Chemical Analysis in Medical Device Biocompatibility Assessment (DRAFT)
- Electronic Submission Template And Resource (eSTAR) for De Novo Classification Requests
- Device Classification and Regulatory Requirements: Procedures for 513(g) Requests for Information
- Predetermined Change Control Plans for Medical Device Modifications (DRAFT)
- Premarket Notification Requirements for Dental Curing Light Devices (DRAFT)
- Premarket Notification Requirements for Dental Composite Resin Devices (DRAFT)
- Bioresearch Monitoring Program Inspections: Processes and Procedures for Site Evaluations (DRAFT)
- Animal Testing Recommendations for Dental Bone Grafting Materials (DRAFT)
- Q-Submission Program for Medical Device Manufacturer Feedback and FDA Meetings (DRAFT)
- Cybersecurity Requirements for Connected Medical Devices with Software (DRAFT)
- Orthopedic Device Metallic and Calcium Phosphate Coatings: Testing and Characterization Requirements (DRAFT)
- Submission Requirements for Terminally Sterilized Medical Devices
- Use of Real-World Data and Real-World Evidence to Support Medical Device Regulatory Decision-Making (DRAFT)
- Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions
- Clinical Electronic Thermometers - Performance, Safety, and Regulatory Requirements
- Modifications to Non-Invasive Remote Monitoring Devices for Patient Monitoring During Public Health Emergencies
- Testing and Labeling of Medical Devices for Magnetic Resonance (MR) Environment Safety and Compatibility
- Premarket Notification Requirements for Magnetic Resonance Diagnostic Devices
- Technical Considerations for Physiologic Closed-Loop Control Medical Devices
- Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
- Non-Clinical Testing Recommendations for Weight Loss and Obesity Treatment Devices (DRAFT)
- Clinical Study Design and Benefit-Risk Considerations for Weight Loss Medical Devices (DRAFT)
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- When Clinical Data is Needed to Support Substantial Equivalence for 510k Submissions (DRAFT)
- Technical Considerations for Long-Term Implantable Medical Devices Requiring 510k (DRAFT)
- Best Practices for Selecting Predicate Devices in 510k Submissions (DRAFT)
- Face Masks and Barrier Face Coverings for Medical Purposes During the COVID-19 Public Health Emergency
- Off-The-Shelf Software in Medical Devices: Documentation Requirements for Premarket Submissions
- Labeling Recommendations for Hydrogen Peroxide-Based Contact Lens Care Products
- Medical Device Development Tools (MDDT) Qualification Program
- Patient-Matched Orthopedic Surgical Guides: Testing, Documentation and Safety Requirements (DRAFT)
- Content of Premarket Submissions for Device Software Functions
- Testing of Tissue Containment Systems Used During Power Morcellation Procedures
- Testing Considerations for Percutaneous Transluminal Angioplasty (PTA) and Specialty Balloon Catheters
- Testing and Performance Requirements for Soft Daily Wear Contact Lenses
- Animal Testing for Medical Device Safety and Performance Evaluation
- Transition Plan for Medical Devices with COVID-19 Emergency Use Authorization After Declaration Termination
- Transition Plan for Medical Devices Distributed Under COVID-19 Emergency Enforcement Policies
- Ultrasonic Diathermy (Physiotherapy) Devices - Technical and Safety Requirements for 510k Submissions
- Marketing Clearance Requirements for Diagnostic Ultrasound Systems and Transducers
- Harmonization of Performance Standards for Diagnostic X-Ray Imaging Systems and Components with IEC Standards
- Impact of Viral Mutations on SARS-CoV-2 Tests: Evaluation and Monitoring Recommendations
- COVID-19 Testing Policy: Validation Requirements and Recommendations for Diagnostic and Serology Tests
- Developing and Responding to Medical Device Marketing Application Deficiencies
- User Fees and Refunds for Premarket Approval Applications and Biologics License Applications
- User Fees and Refunds for 510k Submissions
- User Fee Requirements and Payment Process for 513(g) Requests for Information
- De Novo Classification Request User Fees and Refund Policies
- MDUFA Performance Goals and Processing of 510k Submissions
- FDA Actions on Premarket Approval Applications (PMAs) and Effects on MDUFA Review Goals and Timelines
- De Novo Classification Request Review Process and Performance Goals
- Technical Performance Assessment and Premarket Requirements for Digital Diagnostic Radiology Display Devices
- Policy for Device Software Functions and Mobile Medical Applications
- Computer-Assisted Detection Devices in Radiology: Performance Testing, Documentation and Labeling Requirements
- Clinical Performance Assessment of Computer-Assisted Detection Devices in Radiology
- Regulatory Requirements for Hearing Aids and Personal Sound Amplification Products (PSAPs)
- Technical Performance Assessment of Quantitative Imaging in Radiological Devices
- Clinical Studies for Medical Devices Treating Type 2 Diabetes Through Novel Therapeutic Approaches
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
- Testing and Safety Requirements for Denture Base Resins
- Facet Screw Systems - Safety and Performance Based Pathway
- Testing and Performance Requirements for Surgical Sutures
- Non-Spinal Metallic Fracture Fixation Plates - Safety and Performance Based Testing Requirements
- Patient Engagement in Medical Device Clinical Studies: Roles, Benefits and Best Practices
- Patient-Reported Outcome Instruments in Medical Device Evaluation
- Clinical and Non-Clinical Testing for Medical Devices to Treat Benign Prostatic Hyperplasia (BPH)
- Multiple Patient Use Arthroscopy Pump Tubing Sets - Safety, Testing and Labeling Requirements
- De Novo Classification Process for Novel Medical Devices Without Predicates
- Acceptance Review for De Novo Classification Requests
- Technical Considerations for Nitinol-Containing Medical Devices
- Peripheral Vascular Atherectomy Devices - Content and Testing Requirements for 510k Submissions
- Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Technical Considerations for Q-Submissions and IDE Applications
- Safer Technologies Program for Medical Devices and Device-Led Combination Products with Enhanced Safety Benefits
- Mouse Embryo Assay Testing for Assisted Reproduction Technology Devices
- Product Labeling Requirements for Laparoscopic Power Morcellators in Gynecologic Surgery
- Testing and Performance Requirements for MR Receive-Only Coils for General Diagnostic Use
- Spinal Plating Systems - Safety and Performance Based Testing for Anterior Cervical and Anterior/Lateral Thoracolumbar Devices
- Regulatory Considerations for Microneedling Devices Used in Aesthetic Skin Treatments
- Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Home Use
- Breast Implants - Premarket Requirements for Saline and Silicone Gel-Filled Devices
- Breast Implant Labeling: Patient Communication and Risk Information Requirements
- Blood Glucose Monitoring Systems for Prescription Point-of-Care Use - Performance Standards and Technical Requirements
- Biological Evaluation of Medical Devices Standards in the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
- Basic Safety and Essential Performance Standards for Medical Electrical Equipment Under the ASCA Pilot Program
- Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program for Medical Device Testing Laboratories
- Performance Testing and Safety Requirements for Single-Use Cutaneous Recording Electrodes
- Conventional Foley Urinary Catheters - Performance Testing and Labeling Requirements
- Multiple Function Device Products: Policy and Considerations for Functions Not Subject to FDA Review
- Clinical Investigation Requirements for Prostate Tissue Ablation Systems
- Electronic Copy (eCopy) Program for Medical Device Submissions: Technical Standards and Requirements
- Developing and Labeling Companion Diagnostics for Multiple Oncology Therapeutic Products
- Testing and Performance Requirements for Electrosurgical Devices and Accessories for General Tissue Cutting and Coagulation
- Bone Anchors (Suture Anchors) for Appendicular Skeleton - Content and Testing Requirements for 510k Submissions
- Dual 510k and CLIA Waiver by Application for In Vitro Diagnostic Tests
- Recommended Format and Content for Non-Clinical Bench Performance Testing in Medical Device Premarket Submissions
- Real-Time Review Process for Minor Changes to Approved Medical Devices through PMA Supplements
- Annual Reports for PMA-Approved Medical Devices: Content, Format and Submission Requirements
- Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)
- 30-Day Notice Manufacturing Changes for PMA and HDE Approved Devices
- Coronary, Peripheral, and Neurovascular Guidewires - Performance Testing and Documentation Requirements
- General Wellness Products: Policy for Low Risk Devices and Software Functions
- Changes to Medical Device Definition for Software Functions Under the 21st Century Cures Act
- Safety and Performance Based Pathway for 510k Substantial Equivalence Demonstration
- The Abbreviated 510k Program: Using Guidance Documents, Special Controls, and Standards for Substantial Equivalence Demonstration
- Special 510k Program for Device Modifications: Eligibility Criteria and Submission Requirements
- Humanitarian Device Exemption (HDE) Program: Operational Requirements and Benefit-Risk Assessment
- Humanitarian Use Device (HUD) Designation Requests: Content and Format
- Benefit-Risk Determinations for Medical Device Premarket Review
- Metal Expandable Biliary Stents and Associated Delivery Systems - Content and Testing Requirements for 510k Submissions
- Live Case Presentations During Investigational Device Clinical Trials
- Non-Clinical Testing Recommendations for Machine Perfusion Devices Used to Preserve Vascularized Human Organs for Transplant
- Medical Devices Containing Animal-Derived Materials - Safety and Risk Management Requirements
- 510k Exemption for Unclassified Medical Devices in Selected Product Categories
- Least Burdensome Principles for Medical Device Regulation
- Heparin in Medical Devices and Combination Products: Testing, Labeling and Safety Requirements
- Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices
- Use of Genetic Variant Databases as Sources of Valid Scientific Evidence for Clinical Validity of Genetic Tests
- Acceptance of Clinical Data to Support Medical Device Applications and Submissions
- Medical Device Accessories: Classification and Risk-Based Approach
- Clinical Evaluation of Software as a Medical Device (SaMD)
- Technical Considerations for Additive Manufactured Medical Devices
- Pediatric X-Ray Imaging Device Premarket Submissions: Design, Testing, and Labeling Considerations
- Labeling Requirements for Ultrasonic Surgical Aspirator Devices - Contraindication for Uterine Fibroid Procedures
- Deciding When to Submit a New 510k for Software Changes to Medical Devices
- Deciding When to Submit a New 510k for Changes to an Existing Medical Device
- Establishing Performance Characteristics for Human Papillomavirus (HPV) Detection In Vitro Diagnostic Devices
- Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies
- Procedures for Medical Devices Advisory Committee Panel Meetings
- Certifying Compliance with Clinical Trial Registration Requirements on Form FDA 3674
- Emergency Use Authorization of Medical Products: Requirements and Procedures for Unapproved Products and Uses
- Benefit-Risk Factors in IDE Applications for Medical Device Clinical Investigations
- Postmarket Management of Cybersecurity in Medical Devices
- Mitigating Cross-Contamination Risks in Irrigation Valves and Accessories Used with Flexible Gastrointestinal Endoscopes
- Clinical Trial Considerations for Neurological Devices Intended to Slow, Stop, or Reverse Disease Progression
- Reporting of Computational Modeling and Simulation Studies in Medical Device Submissions
- Solid State X-ray Imaging Devices for Medical Diagnostic Use
- Bipolar Electrosurgical Vessel Sealers for General Surgery - Performance Testing and Labeling Requirements
- Adaptive Designs for Medical Device Clinical Studies
- In Vitro Companion Diagnostic Device and Therapeutic Product Co-Development (DRAFT)
- Leveraging Existing Clinical Data for Pediatric Medical Device Indications
- Technical Performance Assessment of Digital Whole Slide Imaging Systems in Anatomic Pathology
- Radiation Biodosimetry Devices: Performance Testing and Documentation Requirements
- Assessment of Radiofrequency-Induced Heating in Multi-Configuration Passive Medical Devices for MR Conditional Labeling
- Clinical Trial Design and Regulatory Considerations for Nail Appearance and Onychomycosis Treatment Devices
- Assay Development and Validation Requirements for Lamotrigine and Zonisamide Testing in Clinical Laboratories
- List of Device Types That Require Human Factors Data in Premarket Submissions (DRAFT)
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices - Testing and Clinical Requirements
- Corrosion Testing and Surface Characterization Requirements for Intravascular Stents
- Endotoxin Testing for Single-Use Intraocular Ophthalmic Devices
- Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization Test Systems for Bone Marrow Specimens
- Balancing Pre-Market and Post-Market Data Collection for PMA Medical Devices
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
- Safety and Performance of Enteral Device Connectors to Reduce Misconnection Risks
- Recommendations for Labeling Medical Products Without Natural Rubber Latex
- Infusion Pumps - Total Product Life Cycle Recommendations for Safety and Performance
- Design Considerations for Medical Devices Intended for Home Use
- Dual Use Molecular Diagnostic Instruments with FDA-Approved and Non-Approved Functions
- Custom Device Exemption Requirements and Implementation
- IDE Clinical Investigation Decision Process and Requirements
- In Vitro Companion Diagnostic Devices: Development, Review Process, and Labeling Requirements
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- Considering Whether FDA-Regulated Products Involve Nanotechnology
- Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices
- Providing Pediatric Use Information for Medical Device Premarket Submissions Under Section 515A
- Types of Communication During Medical Device Submissions Review
- Premarket Assessment of Medical Devices for Pediatric Use
- Research Use Only and Investigational Use Only In Vitro Diagnostic Products - Labeling and Distribution Requirements
- Design Considerations for Medical Device Pivotal Clinical Studies
- Early Feasibility Medical Device Clinical Studies Including First in Human (FIH) Studies
- Radio Frequency Wireless Technology in Medical Devices
- Migration Studies for In Vitro Diagnostic Devices Moving to New Systems
- Medical Device Product Code Usage and Requirements
- In Vitro Diagnostic Devices for Detection of Antibodies to Borrelia burgdorferi - Performance Characteristics and Testing Requirements
- Pulse Oximeters - Performance Testing and Safety Requirements for SpO2 and Pulse Rate Measurement Devices
- Clinical Study Design for Surgical Ablation Devices Used in Treatment of Atrial Fibrillation Under Direct Visualization
- The Content and Development of Premarket Submissions for Artificial Pancreas Device Systems
- Clinical Investigation of Medical Devices for Treatment of Urinary Incontinence
- Blood Lancets - Single Patient Use Only Labeling Requirements
- Contact Lens Care Product Labeling: Warnings, Instructions and Readability Requirements
- In Vitro Diagnostic Device Studies Exempt from Investigational Device Exemption Requirements
- Non-Clinical Testing and Labeling Requirements for Extracranial Intravascular Stents and Delivery Systems
- Bayesian Statistics in Medical Device Clinical Trials
- Modifications to PMA-Approved Class III Medical Devices: Selecting the Appropriate Regulatory Submission Type
- Clinical Study Design Recommendations for Catheter Ablation Devices in Treatment of Type I Atrial Flutter
- Intravascular Administration Sets and Accessories - Testing and Documentation Requirements
- Clinical Investigation of Nocturnal Home Hemodialysis Delivery Systems
- Total Artificial Disc Devices - Pre-clinical Testing and Clinical Trial Design Requirements
- Coronary and Carotid Embolic Protection Devices - Performance Testing and Labeling Requirements
- Medical Gloves - Premarket Notification, Quality System, Labeling and Compliance Requirements
- Manufacturing Site Inspections and PMA Review Process for Medical Devices
- Biological Indicators for Healthcare Facility Sterilization Process Monitoring - 510k Submission Requirements
- Non-Clinical Testing and Labeling Requirements for Femoral Stem Prostheses in Hip Replacement Systems
- Marketing and Distribution Requirements for Analyte Specific Reagents (ASRs)
- Bundling Multiple Devices and Multiple Indications in Medical Device Submissions
- Neurothrombectomy Devices for Acute Ischemic Stroke Treatment - Pre-clinical and Clinical Testing
- Dental Handpieces - Performance Testing, Safety Requirements and Labeling
- Regulatory Framework for Complementary and Alternative Medicine Products (DRAFT)
- Keratomes and Replacement Keratome Blades for Corneal Surgery
- Use of Leftover Human Specimens in IVD Device Studies: Requirements for IDE Exemption and Privacy Protection
- Tonometers for Measuring Intraocular Pressure - Testing and Performance Requirements
- Dental Curing Lights - Performance Testing and Safety Requirements
- Pharmacogenetic Tests: Premarket Submission Requirements and Performance Validation
- Premarket Notification Requirements for Dental Composite Resin Materials
- Medical Devices with Sharps Injury Prevention Features - Testing, Documentation and Labeling Requirements
- Menstrual Tampons and Menstrual Pads - Testing and Labeling Requirements for 510k Submissions
- Clinical Data Presentation for Orthopedic Implant Device Submissions
- Clinical Studies for Vertebral Body Augmentation Devices in Treatment of Insufficiency Fractures
- Spinal Plating Systems and Vertebral Body Replacement Devices - Content and Testing Requirements for 510k Submissions
- Performance Testing and Labeling Requirements for Surgical and Medical Face Masks
- Vocal Fold Medialization Devices - Testing and Documentation Requirements
- Chemical Indicators for Sterilization Process Monitoring in Healthcare Facilities - Content and Format Requirements for 510k Submissions
- Quality System Information Requirements for Premarket Submissions
- Determining and Managing Off-Label Use Concerns in 510k Submissions
- Resorbable Adhesion Barrier Devices for Abdominal and Pelvic Use - Development and Testing Requirements
- Software Validation for Medical Device Production, Quality Systems, and Device Components
- Reprocessing of Single-Use Medical Devices: Requirements for Third-Party and Hospital Reprocessors
- Changes to Investigational Device Exemption (IDE) Protocols and When FDA Approval is Required
- Early Collaboration Meetings for Medical Device Development: Determination and Agreement Procedures
- Organ Preservation Solutions for Transplantation - Testing and Development Requirements
- Dura Substitute Devices - Premarket Notification (510k) Submissions
- Labeling for Electronic Anti-Theft Systems to Alert Implantable Medical Device Wearers
- Content Considerations for Superficial and Interstitial Photon-Emitting Radionuclide Brachytherapy Sources
- Over-the-Counter Pregnancy Test Devices - 510k Submission Requirements and Performance Standards
- Orthokeratology Rigid Gas Permeable Contact Lenses - Premarket Submissions and Clinical Testing Requirements
- ENT Endoscope Sheaths - Requirements for 510k Submissions
- Premarket Requirements for Nitric Oxide Delivery Systems and Gas Analyzers
- Premarket Notification Requirements for Penile Rigidity Implants
- Liquid Chemical Sterilants and High Level Disinfectants - Content and Format of 510k Submissions
- Inferior Vena Cava Filters - Testing and Labeling Requirements
- Powered Muscle Stimulator Premarket Notification 510k Submissions
- Immunological Testing for Medical Devices: Evaluation and Assessment of Adverse Effects
- Promotion and Recruitment for Investigational Medical Devices
- Keratoprostheses - Special Controls and Testing Requirements for 510k Submissions
- Premarket Notification Requirements for Dermabrasion Devices
- Labeling Claims for Natural Rubber Medical Devices with Reduced Potential for Chemical Sensitization
- Content Considerations for 510k Submissions of Emission Computed Tomography and Nuclear Tomography Systems
- Premarket Notification Requirements for Radionuclide Dose Calibrators
- Non-Automated Sphygmomanometers - Testing and Documentation Requirements
- Aqueous Shunts for Glaucoma Treatment - Testing and Documentation Requirements
- Premarket Notification Requirements for Cardiac Monitors, Heart Rate Meters, and Alarms
- Diagnostic Electrocardiograph Devices - Performance Testing and Safety Requirements
- General vs. Specific Indications for Use in Medical Device Substantial Equivalence Determinations
- Noise Claims in Labeling for Air Conduction Hearing Aids
- Nonprescription Sunglasses - Requirements for Class I Over-The-Counter Devices
- Premarket Notification Requirements for Over-The-Counter Denture Products and Repair Kits
- Adding Lens Finishing Laboratories to Class III Rigid Gas Permeable Contact Lens PMAs
- Male Latex Condoms - Abbreviated 510k Submissions Using Consensus Standards
- Uniform Contraceptive Device Labeling for Pregnancy and STD Protection Information
- AC-Powered Slit Lamp Biomicroscopes - Requirements for 510k Submissions
- Regulatory Requirements for Medical Device Washers and Washer-Disinfectors
- Use of Published Literature and Previously Submitted Data in PMA Supplements for Class III Medical Devices
- Premarket Notification Requirements for Esophageal and Tracheal Prostheses Including Metal Self-Expandable Stents
- Day-100 Meetings for PMA Applications: Procedures and Implementation
- Class II Device 510k Exemption Process and Evaluation Criteria
- Medical Device Kit Component Certification Requirements for 510k Submissions
- Medical Device Convenience Kits - Premarket Notification and Compliance Requirements
- Non-Invasive Blood Pressure Monitoring Devices - Testing and Documentation Requirements for 510k Submissions
- Checklist for Orthopedic External Fixation Device Submissions
- Hydroxyapatite Coated Orthopedic Implants - Information for 510k Submissions
- Review Criteria for Vitreous Aspiration and Cutting Devices
- Investigational Device Exemptions (IDE) Requirements for Refractive Surgery Excimer Lasers
- Format and Content of IDE Progress Reports
- IDE Requirements for Thermal Endometrial Ablation Devices
- Premarket Notification Requirements for Hysteroscopes and Gynecologic Laparoscopes
- Testing Requirements for Healthcare Facility Sterilizers with Non-Traditional Cycle Parameters
- Premarket Notification Requirements for Hysteroscopic and Laparoscopic Insufflators
- Preparing 510k Submissions for Medical Exercise Equipment
- Preparing 510k Submissions for Heating and Cooling Therapeutic Devices
- Premarket Notification Requirements for Manual and Powered Wheelchairs and Three-Wheeled Vehicles
- Testing and Labeling Requirements for Non-Latex Male Condoms
- Content and Format Requirements for Medical Laser 510k Submissions
- Testing of Non-Articulating, Mechanically Locked Modular Implant Components in Orthopedic Devices
- Ceramic Ball Hip Systems - Requirements for 510k Premarket Notifications
- 510k Submissions for Mechanical Lithotripters and Stone Dislodgers in Gastroenterology and Urology
- Premarket Notification Requirements for Sterile Lubricating Jelly Used with Transurethral Surgical Instruments
- Premarket Notification Requirements for Conventional and Antimicrobial Foley Catheters with Balloon Retention
- Extended Laparoscopy Devices - Premarket Notification (510k) Submissions
- Premarket Notification Requirements for Urine Drainage Bags and Accessories
- Testing Requirements for Orthopedic Implants with Modified Metallic Bone-Interface Surfaces
- Regulatory Requirements for Condom-Like Products and Novelty Condoms
- Medical Waste Sharps Containers and Secondary Sharps Containers - Design, Testing, and Labeling Requirements
- Premarket Notification Requirements for Aerosol Delivery Devices: Nebulizers, Metered Dose Inhalers, Spacers and Actuators
- Surgical Gowns and Surgical Drapes - Performance Testing and Labeling Requirements
- Endoscope Washers and Washer/Disinfectors - 510k Review Requirements
- Piston Syringes and Accessories - Review Requirements and Testing Specifications for 510k Submissions
- 510k Requirements for Hypodermic Single Lumen Needles
- Premarket Notification Requirements for Healthcare Facility Sterilizers
- Clinical Electronic Thermometers - Review Requirements and Testing Specifications
- Ureteral Stents - Content and Testing Requirements for 510k Submissions
- Premarket Notification Requirements for Gastroenterology and Urology Biopsy Devices
- In Vitro Diagnostic Devices for Detection of Parvovirus B19 Antibodies in Human Serum and Plasma
- Device Labeling Requirements and Content for Premarket Approval Applications
- Requirements for 510k Submissions for Oxygen Conserving Devices
- Device Master Files - Content, Format, and Submission Requirements
- Clinical and Non-Clinical Testing Requirements for Hysteroscopic Sterilization Devices
- Emergency Use Oxygen Generators and Oxygen Equipment: Flow Rate and Distribution Requirements