Knowledge base
- 13 Jan Modular Submissions for Premarket Approval Applications and Humanitarian Device Exemptions
- 07 Jan Performance Testing and Labeling Requirements for Pulse Oximeters with Focus on Accuracy Across Skin Pigmentation (DRAFT)
- 07 Jan Notifying Device Supply Disruptions and Manufacturing Discontinuances During Public Health Emergencies
- 07 Jan Evaluation of Sex and Gender Differences in Medical Device Clinical Studies (DRAFT)
- 07 Jan Content of Premarket Submissions and Lifecycle Management for Artificial Intelligence and Machine Learning-Enabled Medical Devices (DRAFT)
- 06 Jan Validation of In Vitro Diagnostic Tests for Emerging Pathogens During Public Health Emergencies (DRAFT)
- 17 Dec Global Unique Device Identification Database (GUDID) Data Submission and Management Requirements
- 04 Dec Predetermined Change Control Plans for Artificial Intelligence and Machine Learning-Enabled Device Software Functions
- 26 Nov Ethylene Oxide Sterilization Facility Changes for Class III Medical Devices During EPA Emissions Standards Transition
- 22 Nov Technical Considerations for Non-Spinal Metallic and Polymer Bone Plates and Screws
- 22 Nov Class II Non-Spinal Metallic Bone Screws and Washers - Safety and Performance Based Pathway
- 21 Nov Third Party Review Program for Medical Device 510k and Emergency Use Authorization Reviews
- 17 Oct Long-Term Neurodevelopmental Safety Evaluation of Medical Products Used in Neonates
- 15 Oct Testing and Labeling Requirements for Titanium Alloy Dental Implants and Abutments
- 30 Sep Technical Performance Testing for Dental Cements and Resin-Modified Materials
- 30 Sep Technical Considerations for Dental Ceramics Used in Artificial Teeth and Restorations
- 30 Sep Dental Impression Materials: Performance Criteria and Testing Requirements
- 30 Sep Air-Powered Dental Handpieces and Motors - Performance Testing and Safety Requirements
- 27 Sep X-Ray Equipment Performance Standards and Radiation Safety Requirements
- 23 Sep The Accreditation Scheme for Conformity Assessment (ASCA) Program for Medical Device Testing Laboratories (DRAFT)
- 23 Sep Biocompatibility Testing Standards and Accreditation Requirements in the ASCA Program (DRAFT)
- 23 Sep Basic Safety and Essential Performance Standards in the Accreditation Scheme for Conformity Assessment (ASCA) Program (DRAFT)
- 20 Sep Chemical Analysis in Medical Device Biocompatibility Assessment (DRAFT)
- 10 Sep Appeals Process for Mammography Facilities under MQSA: Adverse Accreditation Decisions, Certificate Actions, and Patient Notifications
- 06 Sep Patient Preference Information in Medical Device Development and Benefit-Risk Assessments (DRAFT)
- 29 Aug Voluntary Malfunction Summary Reporting Program for Medical Devices
- 26 Aug Mammography Quality Standards: Requirements for Facilities, Personnel, Equipment, and Reporting
- 23 Aug Electronic Submission Template And Resource (eSTAR) for De Novo Classification Requests
- 23 Aug Device Classification and Regulatory Requirements: Procedures for 513(g) Requests for Information
- 22 Aug Predetermined Change Control Plans for Medical Device Modifications (DRAFT)
- 19 Aug Electronic Submission of User Manuals and Radiation Safety Reports for Electronic Products
- 16 Jul User Fees for Combination Products and Associated Waivers
- 12 Jul Premarket Notification Requirements for Dental Curing Light Devices (DRAFT)
- 12 Jul Premarket Notification Requirements for Dental Composite Resin Devices (DRAFT)
- 11 Jul Clinical Study Design Recommendations for Devices to Treat Opioid Use Disorder
- 08 Jul Use-Related Risk Analysis for Drug, Biological, and Combination Products: Determining Human Factors Study Needs (DRAFT)
- 28 Jun Essential Drug Delivery Outputs for Drug Delivery Devices and Combination Products (DRAFT)
- 26 Jun Diversity in Clinical Trials: Enrollment Goals and Action Plans for Underrepresented Racial, Ethnic, Sex and Age Groups (DRAFT)
- 25 Jun Laboratory Developed Tests (LDTs) Enforcement Discretion Policy and Phased Compliance Requirements
- 20 Jun Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection
- 05 Jun Bioresearch Monitoring Program Inspections: Processes and Procedures for Site Evaluations (DRAFT)
- 10 May Distinguishing Between Medical Device Servicing and Remanufacturing Activities
- 06 May Policy for Laboratory Tests Used in Response to Chemical, Biological, Radiological, or Nuclear Public Health Emergencies (DRAFT)
- 06 May Enforcement Policies for Unauthorized Diagnostic Tests During Public Health Emergencies (DRAFT)
- 29 Mar Animal Testing Recommendations for Dental Bone Grafting Materials (DRAFT)
- 15 Mar Q-Submission Program for Medical Device Manufacturer Feedback and FDA Meetings (DRAFT)
- 15 Mar Evaluation of Thermal Effects from Medical Devices on Human Tissue (DRAFT)
- 13 Mar Cybersecurity Requirements for Connected Medical Devices with Software (DRAFT)
- 22 Feb Medical Device User Fee Small Business Qualification and Financial Hardship Waivers (DRAFT)
- 02 Feb Remote Regulatory Assessments for FDA-Regulated Products and Establishments (DRAFT)
- 23 Jan Orthopedic Device Metallic and Calcium Phosphate Coatings: Testing and Characterization Requirements (DRAFT)
- 08 Jan Submission Requirements for Terminally Sterilized Medical Devices
- 14 Dec Use of Real-World Data and Real-World Evidence to Support Medical Device Regulatory Decision-Making (DRAFT)
- 21 Nov Translation of Non-English Good Laboratory Practice (GLP) Study Reports (DRAFT)
- 17 Nov Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions
- 03 Nov Review Process for Denied Export Certificates for Medical Devices
- 03 Nov Clinical Electronic Thermometers - Performance, Safety, and Regulatory Requirements
- 02 Nov Manufacturing and Supply Chain Changes for PMA and HDE Devices During Public Health Emergency
- 19 Oct Modifications to Non-Invasive Remote Monitoring Devices for Patient Monitoring During Public Health Emergencies
- 10 Oct Testing and Labeling of Medical Devices for Magnetic Resonance (MR) Environment Safety and Compatibility
- 10 Oct Premarket Notification Requirements for Magnetic Resonance Diagnostic Devices
- 02 Oct Electronic Submission Template And Resource (eSTAR) for 510k Submissions
- 29 Sep Technical Considerations for Physiologic Closed-Loop Control Medical Devices
- 29 Sep Predetermined Change Control Plans for Antimicrobial Susceptibility Test Systems: Updating Breakpoints in Device Labeling
- 28 Sep Development of Products for Prevention and Treatment of Acute and Chronic Graft-Versus-Host Disease (DRAFT)
- 27 Sep Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
- 15 Sep Voluntary Improvement Program (VIP) for Medical Device Manufacturers: Participation Requirements and Implementation
- 15 Sep Non-Clinical Testing Recommendations for Weight Loss and Obesity Treatment Devices (DRAFT)
- 15 Sep Clinical Study Design and Benefit-Risk Considerations for Weight Loss Medical Devices (DRAFT)
- 14 Sep Breakthrough Devices Program: Expedited Development and Review Process for Novel Medical Devices
- 08 Sep Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- 07 Sep When Clinical Data is Needed to Support Substantial Equivalence for 510k Submissions (DRAFT)
- 07 Sep Technical Considerations for Long-Term Implantable Medical Devices Requiring 510k (DRAFT)
- 07 Sep Human Factors Studies and Related Analyses for Combination Products
- 07 Sep Best Practices for Selecting Predicate Devices in 510k Submissions (DRAFT)
- 05 Sep Face Masks and Barrier Face Coverings for Medical Purposes During the COVID-19 Public Health Emergency
- 15 Aug Informed Consent in Clinical Investigations: Requirements, Documentation, and Procedures
- 11 Aug Off-The-Shelf Software in Medical Devices: Documentation Requirements for Premarket Submissions
- 27 Jul Labeling Recommendations for Hydrogen Peroxide-Based Contact Lens Care Products
- 17 Jul Medical Device Development Tools (MDDT) Qualification Program
- 28 Jun Patient-Matched Orthopedic Surgical Guides: Testing, Documentation and Safety Requirements (DRAFT)
- 14 Jun Content of Premarket Submissions for Device Software Functions
- 02 Jun Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
- 26 May Testing of Tissue Containment Systems Used During Power Morcellation Procedures
- 24 May Use of Whole Slide Imaging in GLP Nonclinical Toxicology Studies
- 14 Apr Testing Considerations for Percutaneous Transluminal Angioplasty (PTA) and Specialty Balloon Catheters
- 12 Apr Risk-Based Monitoring of Clinical Investigations
- 30 Mar Process for Research Involving Children that Requires FDA and OHRP Review under 21 CFR 50.54 and 45 CFR 46.407 (DRAFT)
- 28 Mar Testing and Performance Requirements for Soft Daily Wear Contact Lenses
- 28 Mar Animal Testing for Medical Device Safety and Performance Evaluation
- 27 Mar Transition Plan for Medical Devices with COVID-19 Emergency Use Authorization After Declaration Termination
- 27 Mar Transition Plan for Medical Devices Distributed Under COVID-19 Emergency Enforcement Policies
- 21 Feb Ultrasonic Diathermy (Physiotherapy) Devices - Technical and Safety Requirements for 510k Submissions
- 21 Feb Performance Standards for Diagnostic X-Ray Systems and Major Components
- 21 Feb Marketing Clearance Requirements for Diagnostic Ultrasound Systems and Transducers
- 21 Feb Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 Standards
- 21 Feb Harmonization of Performance Standards for Diagnostic X-Ray Imaging Systems and Components with IEC Standards
- 21 Feb Assembly and Installation Requirements for Diagnostic X-ray Equipment and Components
- 12 Jan Technical Considerations for Photobiomodulation Devices in 510k Submissions (DRAFT)
- 12 Jan Impact of Viral Mutations on SARS-CoV-2 Tests: Evaluation and Monitoring Recommendations
- 12 Jan COVID-19 Testing Policy: Validation Requirements and Recommendations for Diagnostic and Serology Tests
- 09 Dec Human Factors Information Needed in Medical Device Marketing Submissions (DRAFT)
- 01 Dec Clinical Investigator Disqualification Procedures and Administrative Actions
- 14 Nov References to Section 201(h) of the FD&C Act Following the Safeguarding Therapeutics Act
- 26 Oct Developing and Responding to Medical Device Marketing Application Deficiencies
- 07 Oct Postmarket Surveillance Studies Requirements for Medical Devices Under Section 522
- 07 Oct Post-Approval Studies for Medical Devices: Protocol Development, Tracking and Reporting Requirements
- 05 Oct User Fees and Refunds for Premarket Approval Applications and Biologics License Applications
- 05 Oct User Fees and Refunds for 510k Submissions
- 05 Oct User Fee Requirements and Payment Process for 513(g) Requests for Information
- 05 Oct De Novo Classification Request User Fees and Refund Policies
- 03 Oct MDUFA Performance Goals and Processing of 510k Submissions
- 03 Oct FDA Actions on Premarket Approval Applications (PMAs) and Effects on MDUFA Review Goals and Timelines
- 03 Oct De Novo Classification Request Review Process and Performance Goals
- 28 Sep Technical Performance Assessment and Premarket Requirements for Digital Diagnostic Radiology Display Devices
- 28 Sep Policy for Device Software Functions and Mobile Medical Applications
- 28 Sep Medical Device Data Systems, Medical Image Storage, and Medical Image Communications Devices - Policy for Functionality and Regulatory Status
- 28 Sep Computer-Assisted Detection Devices in Radiology: Performance Testing, Documentation and Labeling Requirements
- 28 Sep Clinical Performance Assessment of Computer-Assisted Detection Devices in Radiology
- 28 Sep Clinical Decision Support Software Functions: Criteria for Non-Device Classification and Implementation Requirements
- 26 Sep Ethical Considerations for Clinical Investigations of Medical Products in Children (DRAFT)
- 13 Sep Computer Software Assurance for Production and Quality System Software (DRAFT)
- 07 Sep Policy for Monkeypox Testing During the Public Health Emergency
- 17 Aug Regulatory Requirements for Hearing Aids and Personal Sound Amplification Products (PSAPs)
- 17 Aug Applying Previously Cleared IVD Assays to Additional Automated Laboratory Instruments
- 28 Jul Patient Labeling for Laser-Assisted In Situ Keratomileusis (LASIK) Devices (DRAFT)
- 25 Jul Unique Device Identification Policy for Class I and Unclassified Devices: Compliance Dates and Requirements
- 16 Jun Technical Performance Assessment of Quantitative Imaging in Radiological Devices
- 06 Jun Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
- 06 May Clinical Studies for Medical Devices Treating Type 2 Diabetes Through Novel Therapeutic Approaches
- 21 Apr Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
- 13 Apr Testing and Safety Requirements for Denture Base Resins
- 13 Apr Facet Screw Systems - Safety and Performance Based Pathway
- 11 Apr Testing and Performance Requirements for Surgical Sutures
- 11 Apr Non-Spinal Metallic Fracture Fixation Plates - Safety and Performance Based Testing Requirements
- 22 Mar Compliance Requirements for Ophthalmic Drug-Device Combination Products Following Genus Decision
- 02 Mar Procedures for Supervisory Review, Appeals, and Dispute Resolution for Medical Device Decisions
- 02 Mar Including Older Adults in Cancer Clinical Trials: Design and Conduct Considerations
- 26 Jan Premarket Review Pathways for Combination Products
- 26 Jan Patient Engagement in Medical Device Clinical Studies: Roles, Benefits and Best Practices
- 26 Jan Patient-Reported Outcome Instruments in Medical Device Evaluation
- 27 Dec Histopathology Peer Review in Nonclinical Toxicology Studies
- 27 Dec Clinical and Non-Clinical Testing for Medical Devices to Treat Benign Prostatic Hyperplasia (BPH)
- 23 Dec Multiple Patient Use Arthroscopy Pump Tubing Sets - Safety, Testing and Labeling Requirements
- 08 Oct Labeling Requirements for Surgical Staplers and Staples for Internal Use
- 05 Oct De Novo Classification Process for Novel Medical Devices Without Predicates
- 05 Oct Acceptance Review for De Novo Classification Requests
- 29 Sep Safety Reporting Requirements for Clinical Investigators in IND and IDE Studies (DRAFT)
- 20 Aug Export Certification Process and Requirements for FDA-Regulated Products
- 09 Jul Technical Considerations for Nitinol-Containing Medical Devices
- 07 Jul Unique Device Identifier (UDI) Form and Content Requirements
- 02 Jun In Vitro Testing and Labeling for Oral Drug Products Administered via Enteral Feeding Tubes (DRAFT)
- 20 May Peripheral Vascular Atherectomy Devices - Content and Testing Requirements for 510k Submissions
- 20 May Implementation of ICH Q12 Tools and Enablers for Post-Approval CMC Changes in Drug Products and Combination Products (DRAFT)
- 20 May Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Technical Considerations for Q-Submissions and IDE Applications
- 06 Jan Safer Technologies Program for Medical Devices and Device-Led Combination Products with Enhanced Safety Benefits
- 05 Jan Mouse Embryo Assay Testing for Assisted Reproduction Technology Devices
- 30 Dec Product Labeling Requirements for Laparoscopic Power Morcellators in Gynecologic Surgery
- 11 Dec Testing and Performance Requirements for MR Receive-Only Coils for General Diagnostic Use
- 11 Dec Spinal Plating Systems - Safety and Performance Based Testing for Anterior Cervical and Anterior/Lateral Thoracolumbar Devices
- 04 Dec Obtaining FDA Feedback for Combination Products: Best Practices and Meeting Procedures
- 13 Nov Certificates of Confidentiality for Non-Federally Funded Research: Protection of Human Subject Privacy in FDA-Regulated Studies
- 10 Nov Regulatory Considerations for Microneedling Devices Used in Aesthetic Skin Treatments
- 16 Oct Testing for Biotin Interference in In Vitro Diagnostic Devices Using Biotin/Avidin Technology
- 29 Sep Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Home Use
- 29 Sep Breast Implants - Premarket Requirements for Saline and Silicone Gel-Filled Devices
- 29 Sep Breast Implant Labeling: Patient Communication and Risk Information Requirements
- 29 Sep Blood Glucose Monitoring Systems for Prescription Point-of-Care Use - Performance Standards and Technical Requirements
- 25 Sep Biological Evaluation of Medical Devices Standards in the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
- 25 Sep Basic Safety and Essential Performance Standards for Medical Electrical Equipment Under the ASCA Pilot Program
- 25 Sep Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program for Medical Device Testing Laboratories
- 15 Sep Recognition and Withdrawal Process for Voluntary Consensus Standards
- 14 Aug Performance Testing and Safety Requirements for Single-Use Cutaneous Recording Electrodes
- 14 Aug Conventional Foley Urinary Catheters - Performance Testing and Labeling Requirements
- 14 Aug Civil Money Penalties Related to ClinicalTrials.gov Requirements
- 29 Jul Multiple Function Device Products: Policy and Considerations for Functions Not Subject to FDA Review
- 15 Jul Electronic Submission Requirements for Medical Device Submissions
- 15 Jul Clinical Investigation Requirements for Prostate Tissue Ablation Systems
- 29 Jun Uniform Inspection Process and Communications for Medical Device Establishments
- 04 May Classification and Special Controls for Posterior Cervical Screw Systems
- 27 Apr Electronic Copy (eCopy) Program for Medical Device Submissions: Technical Standards and Requirements
- 22 Apr Requesting Nonbinding Feedback on Form FDA 483 Inspectional Observations
- 21 Apr Reliability Requirements for Emergency-Use Auto-Injectors (DRAFT)
- 13 Apr Developing and Labeling Companion Diagnostics for Multiple Oncology Therapeutic Products
- 27 Mar Appeals Process and Documentation Requirements for Significant Medical Device Submission Decisions
- 17 Mar Safety Considerations for Flow Restrictors in Oral Liquid Drug Products to Prevent Accidental Ingestion by Children (DRAFT)
- 09 Mar Testing and Performance Requirements for Electrosurgical Devices and Accessories for General Tissue Cutting and Coagulation
- 03 Mar Bone Anchors (Suture Anchors) for Appendicular Skeleton - Content and Testing Requirements for 510k Submissions
- 02 Mar Product Recalls, Removals, and Corrections: Procedures and Best Practices
- 26 Feb Dual 510k and CLIA Waiver by Application for In Vitro Diagnostic Tests
- 26 Feb CLIA Waiver Applications for In Vitro Diagnostic Devices - Demonstrating Simplicity and Insignificant Risk of Erroneous Results
- 20 Dec Recommended Format and Content for Non-Clinical Bench Performance Testing in Medical Device Premarket Submissions
- 19 Dec Bridging Strategies for Drug-Device and Biologic-Device Combination Products (DRAFT)
- 16 Dec Real-Time Review Process for Minor Changes to Approved Medical Devices through PMA Supplements
- 16 Dec Annual Reports for PMA-Approved Medical Devices: Content, Format and Submission Requirements
- 16 Dec Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)
- 16 Dec 30-Day Notice Manufacturing Changes for PMA and HDE Approved Devices
- 10 Oct Labeling for Intravascular Devices with Lubricious Coatings
- 10 Oct Coronary, Peripheral, and Neurovascular Guidewires - Performance Testing and Documentation Requirements
- 27 Sep General Wellness Products: Policy for Low Risk Devices and Software Functions
- 27 Sep Changes to Medical Device Definition for Software Functions Under the 21st Century Cures Act
- 20 Sep Safety and Performance Based Pathway for 510k Substantial Equivalence Demonstration
- 13 Sep The Abbreviated 510k Program: Using Guidance Documents, Special Controls, and Standards for Substantial Equivalence Demonstration
- 13 Sep Special 510k Program for Device Modifications: Eligibility Criteria and Submission Requirements
- 06 Sep Humanitarian Device Exemption (HDE) Program: Operational Requirements and Benefit-Risk Assessment
- 05 Sep Humanitarian Use Device (HUD) Designation Requests: Content and Format
- 30 Aug Benefit-Risk Determinations for Medical Device Premarket Review
- 30 Aug Benefit-Risk Assessment with Uncertainty in Medical Device Premarket Submissions
- 26 Jul Metal Expandable Biliary Stents and Associated Delivery Systems - Content and Testing Requirements for 510k Submissions
- 22 Jul Postmarketing Safety Reporting Requirements for Combination Products
- 18 Jul Technical Specifications for Next Generation Sequencing Data in Antiviral Drug Development
- 11 Jul Live Case Presentations During Investigational Device Clinical Trials
- 08 May Performance Standard Requirements for Fluoroscopic X-Ray Systems: Timing, Safety Features and Display Requirements
- 08 May Non-Clinical Testing Recommendations for Machine Perfusion Devices Used to Preserve Vascularized Human Organs for Transplant
- 08 May Laser Illuminated Projectors (LIPs) - Classification, Safety Requirements and Labeling
- 26 Apr Unique Device Identification Requirements for Convenience Kits
- 26 Apr Testing and Characterization of Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices
- 20 Apr Compliance Policy for Combination Product Postmarketing Safety Reporting Requirements
- 15 Mar Medical Devices Containing Animal-Derived Materials - Safety and Risk Management Requirements
- 01 Mar Release of Laboratory Test Results to Responsible Parties Without Freedom of Information Act Requests
- 15 Feb Medical Devices Used in Recovery, Isolation, and Delivery of Regenerative Medicine Advanced Therapies
- 08 Feb Public Warning and Notification of Recalls Under Part 7
- 08 Feb 510k Exemption for Unclassified Medical Devices in Selected Product Categories
- 05 Feb Least Burdensome Principles for Medical Device Regulation
- 01 Feb Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices
- 17 Dec Manufacturing Site Changes for PMA-Approved Medical Devices: When to Submit a Supplement and Documentation Requirements
- 11 Oct Impact of Revised Common Rule on FDA-Regulated Clinical Investigations
- 03 Oct Selection of Package Type Terms and Discard Statements for Injectable Medical Products
- 25 Sep Benefit-Risk Factors to Consider When Evaluating Substantial Equivalence in 510k Submissions
- 20 Sep Heparin in Medical Devices and Combination Products: Testing, Labeling and Safety Requirements
- 14 Sep Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices
- 01 Aug Medical Device User Fee Small Business Qualification and Certification Process
- 15 Jun Distribution of LOINC Codes for In Vitro Diagnostic Tests by Manufacturers
- 13 Jun Medical Product Communications That Are Consistent With FDA-Required Labeling
- 13 Jun Health Care Economic Information Communications to Payors for Medical Devices
- 17 May Written Procedures for Institutional Review Boards (IRBs): Administrative Requirements and Operations
- 13 Apr Use of Next Generation Sequencing in the Diagnosis of Germline Diseases
- 13 Apr Use of Genetic Variant Databases as Sources of Valid Scientific Evidence for Clinical Validity of Genetic Tests
- 02 Mar Standards for Drug Supply Chain Transaction Information, History and Statements (DRAFT)
- 21 Feb Acceptance of Clinical Data to Support Medical Device Applications and Submissions
- 14 Feb How to Submit a Pre-Request for Designation (Pre-RFD) for Product Classification and Center Assignment
- 20 Dec Medical Device Accessories: Classification and Risk-Based Approach
- 18 Dec Investigational In Vitro Diagnostic Devices Used in Therapeutic Product Clinical Trials (DRAFT)
- 08 Dec Clinical Evaluation of Software as a Medical Device (SaMD)
- 05 Dec Technical Considerations for Additive Manufactured Medical Devices
- 05 Dec IDE Device Categorization for Medicare Coverage: Category A vs Category B Determination
- 28 Nov Pediatric X-Ray Imaging Device Premarket Submissions: Design, Testing, and Labeling Considerations
- 17 Nov Direct Marking of Devices with Unique Device Identification (UDI) Requirements for Reusable Medical Devices
- 30 Oct Sharing Patient-Specific Information from Medical Devices with Patients
- 30 Oct Labeling Requirements for Ultrasonic Surgical Aspirator Devices - Contraindication for Uterine Fibroid Procedures
- 25 Oct Deciding When to Submit a New 510k for Software Changes to Medical Devices
- 25 Oct Deciding When to Submit a New 510k for Changes to an Existing Medical Device
- 02 Oct Administrative Procedures for CLIA Categorization of In Vitro Diagnostic Tests
- 25 Sep Minutes of Institutional Review Board (IRB) Meetings - Content and Documentation Requirements
- 25 Sep Classification of Products as Drugs or Devices: Interpretation and Determination Process
- 15 Sep Establishing Performance Characteristics for Human Papillomavirus (HPV) Detection In Vitro Diagnostic Devices
- 12 Sep Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies
- 06 Sep Design Considerations and Recommendations for Interoperable Medical Devices
- 01 Sep Procedures for Medical Devices Advisory Committee Panel Meetings
- 31 Aug Use of Real-World Data to Generate Evidence for Medical Device Regulatory Decisions
- 07 Jun Certifying Compliance with Clinical Trial Registration Requirements on Form FDA 3674
- 13 Jan Emergency Use Authorization of Medical Products: Requirements and Procedures for Unapproved Products and Uses
- 13 Jan Benefit-Risk Factors in IDE Applications for Medical Device Clinical Investigations
- 11 Jan Current Good Manufacturing Practice Requirements for Combination Products
- 28 Dec Postmarket Management of Cybersecurity in Medical Devices
- 27 Dec Benefit-Risk Factors in Medical Device Product Availability, Compliance, and Enforcement Decisions
- 15 Dec Use of Electronic Informed Consent in Clinical Investigations
- 14 Dec Public Notification of Medical Device Emerging Signals: New Safety Information and Adverse Events
- 29 Nov Mitigating Cross-Contamination Risks in Irrigation Valves and Accessories Used with Flexible Gastrointestinal Endoscopes
- 08 Nov Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
- 07 Nov Clinical Trial Considerations for Neurological Devices Intended to Slow, Stop, or Reverse Disease Progression
- 31 Oct Labeling Requirements for Permanent Hysteroscopic Tubal Implants for Female Sterilization
- 26 Oct Collection and Reporting of Race and Ethnicity Data in Clinical Trials
- 21 Sep Reporting of Computational Modeling and Simulation Studies in Medical Device Submissions
- 01 Sep Solid State X-ray Imaging Devices for Medical Diagnostic Use
- 24 Aug Patient Preference Information in Medical Device Development, Clinical Trials, and Regulatory Decision Making
- 15 Aug Bipolar Electrosurgical Vessel Sealers for General Surgery - Performance Testing and Labeling Requirements
- 27 Jul Adaptive Designs for Medical Device Clinical Studies
- 15 Jul In Vitro Companion Diagnostic Device and Therapeutic Product Co-Development (DRAFT)
- 29 Jun Evaluating Appearance Issues and Granting Participation Authorizations for Advisory Committee Members (DRAFT)
- 21 Jun Leveraging Existing Clinical Data for Pediatric Medical Device Indications
- 20 Apr Technical Performance Assessment of Digital Whole Slide Imaging Systems in Anatomic Pathology
- 18 Apr Radiation Biodosimetry Devices: Performance Testing and Documentation Requirements
- 22 Mar Assessment of Radiofrequency-Induced Heating in Multi-Configuration Passive Medical Devices for MR Conditional Labeling
- 07 Mar Clinical Trial Design and Regulatory Considerations for Nail Appearance and Onychomycosis Treatment Devices
- 09 Feb Assay Development and Validation Requirements for Lamotrigine and Zonisamide Testing in Clinical Laboratories
- 03 Feb List of Device Types That Require Human Factors Data in Premarket Submissions (DRAFT)
- 03 Feb Applying Human Factors Engineering and Usability Engineering to Medical Devices
- 21 Jan Special Controls for Implanted Blood Access Devices for Hemodialysis
- 15 Dec Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices - Testing and Clinical Requirements
- 09 Dec Premarket Regulatory Requirements for Liquid Barrier Protection Claims in Medical Gowns
- 18 Aug Corrosion Testing and Surface Characterization Requirements for Intravascular Stents
- 17 Aug Endotoxin Testing for Single-Use Intraocular Ophthalmic Devices
- 09 Jul Meetings with the Office of Orphan Products Development: Procedures and Best Practices
- 17 Jun Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization Test Systems for Bone Marrow Specimens
- 13 Apr Balancing Pre-Market and Post-Market Data Collection for PMA Medical Devices
- 17 Mar Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
- 11 Feb Safety and Performance of Enteral Device Connectors to Reduce Misconnection Risks
- 19 Dec Safety of Children's Toy Laser Products
- 02 Dec Recommendations for Labeling Medical Products Without Natural Rubber Latex
- 02 Dec Infusion Pumps - Total Product Life Cycle Recommendations for Safety and Performance
- 24 Nov Design Considerations for Medical Devices Intended for Home Use
- 12 Nov Dual Use Molecular Diagnostic Instruments with FDA-Approved and Non-Approved Functions
- 15 Oct Distinguishing Between Medical Device Recalls and Device Enhancements
- 24 Sep Custom Device Exemption Requirements and Implementation
- 27 Aug Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices
- 22 Aug Sex-Specific Considerations in Medical Device Clinical Studies: Patient Enrollment, Data Analysis and Reporting
- 20 Aug Unique Device Identification System: Implementation and Compliance Requirements
- 19 Aug IDE Clinical Investigation Decision Process and Requirements
- 06 Aug In Vitro Companion Diagnostic Devices: Development, Review Process, and Labeling Requirements
- 28 Jul Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- 23 Jun Considering Whether FDA-Regulated Products Involve Nanotechnology
- 19 Jun Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices
- 23 May Transfer of Clinical Investigation Oversight Between Institutional Review Boards
- 01 May Providing Pediatric Use Information for Medical Device Premarket Submissions Under Section 515A
- 04 Apr Types of Communication During Medical Device Submissions Review
- 31 Mar Same-Sex Marriage Recognition in Regulatory Definitions of Spouse and Family
- 27 Mar Medical Device Tracking Requirements and Implementation Procedures
- 24 Mar Premarket Assessment of Medical Devices for Pediatric Use
- 28 Feb Public Disclosure of Advisory Committee Members' Financial Interests and Waivers
- 13 Feb Electronic Medical Device Reporting: Questions and Answers on Electronic Submission of Postmarket Reports
- 25 Nov Research Use Only and Investigational Use Only In Vitro Diagnostic Products - Labeling and Distribution Requirements
- 07 Nov Design Considerations for Medical Device Pivotal Clinical Studies
- 01 Oct Early Feasibility Medical Device Clinical Studies Including First in Human (FIH) Studies
- 18 Sep Electronic Source Data in Clinical Investigations
- 27 Aug IRB Responsibilities for Reviewing Investigator Qualifications, Research Sites, and IND/IDE Requirements
- 14 Aug Radio Frequency Wireless Technology in Medical Devices
- 07 Aug Risk-Based Monitoring in Clinical Investigations of Medical Products
- 07 Jun Technical Considerations for Pen, Jet, and Related Injectors Submitted in Drug and Biological Product Applications
- 15 May Public Participation in Open Public Hearing Sessions of Advisory Committee Meetings
- 25 Apr Migration Studies for In Vitro Diagnostic Devices Moving to New Systems
- 10 Apr Medical Device Product Code Usage and Requirements
- 01 Apr Exception from Informed Consent Requirements for Emergency Research
- 31 Mar Glass Syringes: Testing and Performance Requirements for Connectivity with Needles and Other Devices (DRAFT)
- 27 Mar In Vitro Diagnostic Devices for Detection of Antibodies to Borrelia burgdorferi - Performance Characteristics and Testing Requirements
- 06 Mar Retinal Prostheses: Clinical, Non-Clinical, and Safety Recommendations for Electrical Stimulation Devices
- 03 Mar Pulse Oximeters - Premarket Notification Submissions 510k
- 14 Feb Clinical Study Design for Surgical Ablation Devices Used in Treatment of Atrial Fibrillation Under Direct Visualization
- 01 Feb Financial Disclosure Requirements for Clinical Investigators
- 18 Jan Postapproval Changes to Combination Products: Marketing Submission Requirements (DRAFT)
- 09 Nov The Content and Development of Premarket Submissions for Artificial Pancreas Device Systems
- 27 Feb Continuing Review of Clinical Investigations by Institutional Review Boards (IRBs)
- 19 Aug Exculpatory Language in Informed Consent Documents for Clinical Research (DRAFT)
- 14 Jul In Vitro Diagnostic Devices for Detection and Differentiation of Influenza Viruses - Performance Testing and Validation Requirements
- 14 Apr How to Submit a Request for Designation (RFD) for Product Classification and FDA Center Assignment
- 07 Mar Clinical Study Design for Medical Devices Treating Urinary Incontinence
- 28 Nov Blood Lancets - Single Patient Use Only Labeling Requirements
- 29 Sep Including Manufacturer's URL on Electronic Product Labels
- 02 Sep Impact-Resistant Lenses in Eyeglasses and Sunglasses: Testing, Documentation, and Import Requirements
- 15 Aug Contact Lens Care Product Labeling: Warnings, Instructions and Readability Requirements
- 25 Jun In Vitro Diagnostic Device Studies Exempt from Investigational Device Exemption Requirements
- 17 Apr Non-Clinical Testing and Labeling Requirements for Extracranial Intravascular Stents and Delivery Systems
- 05 Feb Bayesian Statistics in Medical Device Clinical Trials
- 04 Feb Bayesian Statistics in Medical Device Clinical Trials: Design, Analysis and Implementation
- 06 Jan Adding Imaging Contrast Indications to Medical Devices Used with Approved Imaging Drugs
- 09 Dec Patient-Reported Outcome Measures: Development, Implementation and Evaluation in Clinical Trials
- 23 Oct Investigator Responsibilities - Protecting Human Subjects and Ensuring Data Integrity in Clinical Research
- 09 Jul IRB Registration Requirements and Procedures
- 01 Jul Color Additive Petitions: Chemical and Technical Requirements for Food, Drugs, Cosmetics, and Medical Devices
- 14 Jan Adverse Event Reporting to IRBs Under FDA-Regulated Research
- 23 Dec Safety Considerations for Hand-Held X-Ray Equipment: Radiation Protection and Testing Requirements
- 11 Dec Modifications to PMA-Approved Class III Medical Devices: Selecting the Appropriate Regulatory Submission Type
- 01 Oct Data Retention Requirements When Clinical Trial Subjects Withdraw from FDA-Regulated Studies
- 05 Aug Clinical Study Design Recommendations for Catheter Ablation Devices in Treatment of Type I Atrial Flutter
- 01 Aug Voting Procedures for Advisory Committee Meetings
- 01 Aug Preparation and Submission of Advisory Committee Briefing Materials for Public Release
- 11 Jul Intravascular Administration Sets and Accessories - Testing and Documentation Requirements
- 11 Jul Import Surveillance and Detention of Medical Gloves that Fail Water Leak Testing
- 11 Jul Import Surveillance and Detention Process for Condoms Failing Water Leak Testing Requirements
- 23 Apr Hemodialysis Blood Tubing Sets - Performance, Testing, and Labeling Requirements
- 15 Apr Clinical Investigation of Nocturnal Home Hemodialysis Delivery Systems
- 11 Apr Total Artificial Disc Devices - Pre-clinical Testing and Clinical Trial Design Requirements
- 25 Feb Container and Closure System Integrity Testing as an Alternative to Sterility Testing for Stability Protocols
- 15 Feb Coronary and Carotid Embolic Protection Devices - Performance Testing and Labeling Requirements
- 22 Jan Medical Gloves - Premarket Notification, Quality System, Labeling and Compliance Requirements
- 08 Jan Manufacturing Site Inspections and PMA Review Process for Medical Devices
- 30 Oct Inspection and Field Testing Requirements for Sunlamp Products and UV-Emitting Devices
- 30 Oct Inspection and Field Testing Requirements for Radiation-Emitting Electronic Products
- 04 Oct Biological Indicators for Healthcare Facility Sterilization Process Monitoring - 510k Submission Requirements
- 24 Sep Laser Light Show Variance Renewal and Amendment Procedures
- 18 Sep Safety and Performance Requirements for Cabinet X-ray Security Screening and Industrial Quality Control Systems
- 17 Sep Non-Clinical Testing and Labeling Requirements for Femoral Stem Prostheses in Hip Replacement Systems
- 13 Sep Marketing and Distribution Requirements for Analyte Specific Reagents (ASRs)
- 19 Jul Dear Doctor Letters for Implantable Cardioverter Defibrillator Recalls: Content and Format Recommendations
- 01 Jul Jurisdictional Determinations for HCT/P Processing Devices: CBER vs CDRH Assignment
- 22 Jun Bundling Multiple Devices and Multiple Indications in Medical Device Submissions
- 18 Jun Neurothrombectomy Devices for Acute Ischemic Stroke Treatment - Pre-clinical and Clinical Testing
- 02 May Dental Handpieces - Performance Testing, Safety Requirements and Labeling
- 22 Mar Alternative Labeling Methods for Laser Products
- 12 Mar Statistical Guidance for Reporting Diagnostic Test Results with Qualitative Outcomes
- 27 Feb Regulatory Framework for Complementary and Alternative Medicine Products (DRAFT)
- 01 Dec Process for Clinical Investigations Involving Children Requiring Additional Safeguards
- 24 Nov Regulatory Requirements for Decorative Non-Corrective Contact Lenses
- 18 Sep Keratomes and Replacement Keratome Blades for Corneal Surgery
- 01 Sep Early Development Considerations for Combination Products
- 01 May Reprocessor Identification Requirements for Reprocessed Single-Use Devices
- 01 May Color Additives in Contact Lenses: Preparing and Submitting Petitions
- 25 Apr Use of Leftover Human Specimens in IVD Device Studies: Requirements for IDE Exemption and Privacy Protection
- 28 Mar Establishment and Operation of Clinical Trial Data Monitoring Committees
- 27 Mar Tonometers for Measuring Intraocular Pressure - Testing and Performance Requirements
- 27 Mar Dental Curing Lights - Performance Testing and Safety Requirements
- 10 Mar Hospital Bed System Dimensional and Safety Requirements to Reduce Patient Entrapment
- 28 Feb Electronic Distribution of Product Information and Safety Communications
- 09 Feb Pharmacogenetic Tests: Premarket Submission Requirements and Performance Validation
- 01 Feb Electronic Submission Format Requirements for Orphan Drug and Humanitarian Use Device Designation Requests (DRAFT)
- 05 Jan Exemption from Reporting Requirements for Low Risk Class I Laser Products
- 05 Nov High-Intensity Mercury Vapor Discharge Lamps: Scope of Performance Standard and Requirements for General Purpose Lighting vs. Specialized Applications
- 25 Oct Premarket Notification Requirements for Dental Composite Resin Materials
- 22 Sep C-Reactive Protein (CRP) Assays - Premarket Notification 510k Submissions
- 08 Aug Sharps Injury Prevention Features in Medical Devices: Testing and Documentation Requirements
- 26 Jul Menstrual Tampons and Menstrual Pads - Testing and Labeling Requirements for 510k Submissions
- 01 Apr Civil Penalties for Electronic Product Radiation Control Violations
- 01 Mar Pharmacogenomic Data Submissions in Drug Development and Biomarker Classification
- 28 Feb X-ray Tube Housing Assembly Reloading Facilities: Registration, Listing and Inspection Requirements
- 28 Feb Regulatory Requirements and Enforcement Actions for Defective Sunlamp Products Manufactured Before May 7, 1980
- 28 Feb Regulatory Actions and Civil Penalties for Non-Compliant Diagnostic X-ray Equipment Assemblers
- 08 Feb Cybersecurity for Networked Medical Devices with Off-The-Shelf Software
- 14 Jan Cybersecurity Maintenance for Medical Devices with Off-The-Shelf Software
- 01 Dec Format for Clinical Data Presentations in Orthopedic Implant Device Submissions
- 23 Oct Clinical Studies for Vertebral Body Augmentation Devices in Treatment of Insufficiency Fractures
- 02 Jun Validation Data Requirements for Reprocessed Single-Use Medical Devices
- 03 May Dispute Resolution Process for Combination Product Review Timelines
- 02 May Spinal Plating Systems and Vertebral Body Replacement Devices - Content and Testing Requirements for 510k Submissions
- 04 Mar Performance Testing and Labeling Requirements for Surgical and Medical Face Masks
- 12 Feb Vocal Fold Medialization Devices - Testing and Documentation Requirements
- 18 Dec Chemical Indicators for Sterilization Process Monitoring in Healthcare Facilities - Content and Format Requirements for 510k Submissions
- 05 Sep Electronic Records and Electronic Signatures - Scope and Application
- 04 Sep Assembly, Installation, Adjustment and Testing Information Requirements for Diagnostic X-Ray Systems
- 16 Jul Registration and Listing Requirements for Single-Use Device Reprocessors and Hospitals
- 02 Jun Pediatric Expertise for Advisory Panels Reviewing Medical Device Submissions
- 03 Feb Quality System Information Requirements for Premarket Submissions
- 02 Dec Determining and Managing Off-Label Use Concerns in 510k Submissions
- 11 Nov Medical Device Reporting for Needlestick and Other Sharps Injuries
- 12 Jul Military Laser Products: Department of Defense Exemption Requirements and Compliance Process
- 17 Jun Resorbable Adhesion Barrier Devices for Abdominal and Pelvic Surgery - Development and Testing Requirements
- 11 Jan Software Validation for Medical Device Production, Quality Systems, and Device Components
- 07 Jan Sterilization of Convenience Kits: Component Compatibility and Validation Requirements
- 30 Jul Labeling Requirements for Reprocessed Single-Use Medical Devices
- 06 Jul Reprocessing of Single-Use Medical Devices: Requirements for Third-Party and Hospital Reprocessors
- 20 Jun Labeling Requirements for Keratomes Used in LASIK Surgery
- 28 May Changes to Investigational Device Exemption (IDE) Protocols and When FDA Approval is Required
- 26 May Laser Light Show Projectors - Variance Requirements and Safety Standards
- 19 Apr Writing Medical Device Patient Labeling: Content and Design Considerations
- 27 Feb Early Collaboration Meetings for Medical Device Development: Determination and Agreement Procedures
- 15 Jan Organ Preservation Solutions for Transplantation - Testing and Development Requirements
- 08 Nov Dura Substitute Devices - Premarket Notification (510k) Submissions
- 15 Aug Labeling for Electronic Anti-Theft Systems to Alert Implantable Medical Device Wearers
- 08 Aug Use of Data from Approved PMAs to Support New Device Approvals After 6 Years
- 01 Aug Content Considerations for Superficial and Interstitial Photon-Emitting Radionuclide Brachytherapy Sources
- 21 Jul Over-the-Counter Pregnancy Test Devices - 510k Submission Requirements and Performance Standards
- 05 Jul Consolidated Annual Reporting for Pacemaker Product Lines (1-CARD)
- 09 Apr Orthokeratology Rigid Gas Permeable Contact Lenses - Premarket Submissions and Clinical Testing Requirements
- 11 Mar ENT Endoscope Sheaths - Requirements for 510k Submissions
- 01 Feb Testing Requirements for Metallic Plasma Sprayed Coatings on Orthopedic Implants
- 24 Jan Premarket Requirements for Nitric Oxide Delivery Systems and Gas Analyzers
- 15 Jan Premarket Notification Requirements for Penile Rigidity Implants
- 12 Jan Preparation of IDE Applications for Spinal Systems: Pedicle Screws, Intervertebral Body Fusion, Vertebral Body Replacement, and Disc Replacement Devices
- 02 Jan Liquid Chemical Sterilants and High Level Disinfectants - Content and Format of 510k Submissions
- 25 Nov Inferior Vena Cava Filters - Testing and Labeling Requirements
- 08 Jun Powered Muscle Stimulator Premarket Notification 510k Submissions
- 07 May Clinical Study Design for Cardiac Ablation Systems in Treatment of Ventricular Tachycardia
- 05 May Immunological Testing for Medical Devices: Evaluation and Assessment of Adverse Effects
- 19 Mar Promotion and Recruitment for Investigational Medical Devices
- 02 Mar Keratoprostheses - Special Controls and Testing Requirements for 510k Submissions
- 01 Mar Preparation of 510k Submissions for General Surgical Meshes
- 01 Mar Premarket Notification Requirements for Dermabrasion Devices
- 12 Jan Labeling Claims for Reduced Chemical Sensitivity in Natural Rubber Medical Devices
- 02 Dec Content Considerations for 510k Submissions of Emission Computed Tomography and Nuclear Tomography Systems
- 19 Nov Premarket Notification Requirements for Radionuclide Dose Calibrators
- 18 Nov Non-Automated Sphygmomanometers - Testing and Documentation Requirements
- 15 Nov Aqueous Shunts for Glaucoma Treatment - Testing and Documentation Requirements
- 09 Nov Categories of Research Eligible for Expedited IRB Review
- 06 Nov Documentation Requirements for Medical Devices Containing Animal-Derived Materials
- 04 Nov Premarket Notification Requirements for Cardiac Monitors, Heart Rate Meters, and Alarms
- 04 Nov Diagnostic Electrocardiograph Devices - Performance Testing and Safety Requirements
- 03 Nov General vs. Specific Indications for Use in Medical Device Substantial Equivalence Determinations
- 20 Oct Noise Claims in Labeling for Air Conduction Hearing Aids
- 08 Oct Nonprescription Sunglasses - Requirements for Class I Over-The-Counter Devices
- 29 Sep Powered Suction Pump 510k Submissions: Information Requirements and Testing Recommendations
- 17 Aug Premarket Notification Requirements for Over-The-Counter Denture Products and Repair Kits
- 13 Aug Accidental Radioactive Contamination of Human Food and Animal Feeds: Recommendations for State and Local Agencies
- 10 Aug Adding Lens Finishing Laboratories to Class III Rigid Gas Permeable Contact Lens PMAs
- 23 Jul Male Latex Condoms - Abbreviated 510k Submissions Using Consensus Standards
- 22 Jul Uniform Contraceptive Device Labeling for Pregnancy and STD Protection Information
- 07 Jul AC-Powered Slit Lamp Biomicroscopes - Requirements for 510k Submissions
- 01 Jun Regulatory Requirements for Medical Device Washers and Washer-Disinfectors
- 19 May Use of Published Literature and Previously Submitted Data in PMA Supplements for Class III Medical Devices
- 27 Apr Premarket Notification Requirements for Esophageal and Tracheal Prostheses Including Metal Self-Expandable Stents
- 18 Feb Day-100 Meetings for PMA Applications: Procedures and Implementation
- 18 Feb Class II Device 510k Exemption Process and Evaluation Criteria
- 03 Dec Industry-Supported Scientific and Educational Activities: Maintaining Independence from Promotional Influence
- 20 Nov Direct Final Rulemaking Procedures and Implementation Process
- 01 Nov Maintaining Independence of Industry-Supported Scientific and Educational Activities
- 30 Jun Medical Device Kit Component Certification Requirements for 510k Submissions
- 19 May Medical Device Convenience Kits - Premarket Notification and Compliance Requirements
- 11 Mar Design Controls for Medical Device Manufacturers
- 09 Mar Non-Invasive Blood Pressure Monitoring Devices - Testing and Documentation Requirements for 510k Submissions
- 20 Feb Checklist for Orthopedic External Fixation Device Submissions
- 19 Feb Hydroxyapatite Coated Orthopedic Implants - Information for 510k Submissions
- 31 Jan Review Criteria for Phacofragmentation Systems Used in Cataract Surgery
- 30 Jan Review Criteria for Vitreous Aspiration and Cutting Devices
- 01 Dec Export Requirements for Products Not Approved for Sale in the United States
- 30 Oct Barrier Devices for STD Protection During Oral Sex - Requirements for 510k Submissions
- 09 Oct IDE Content Requirements for Refractive Surgery Laser Clinical Investigations
- 05 Sep Use of Visible Laser Beam as Emission Indicator for Class II and Class IIIa Laser Products
- 05 Sep Alternative Identification Labeling Requirements for Class I Laser Products Integrated into Other Products
- 11 Aug Use of Reporting Site Registration Number for Medical Device Reports (MDR) Instead of Manufacturing Site Number
- 15 Jul Medical Device Reporting: Manufacturer Report Number Format Variances
- 06 Jun Laser Light Shows and Displays: Requirements for Aircraft Safety and Visual Control
- 31 May Format and Content of IDE Progress Reports
- 01 Apr Medical Device Reporting Requirements for User Facilities
- 13 Mar IDE Requirements for Thermal Endometrial Ablation Devices
- 07 Mar Premarket Notification Requirements for Hysteroscopes and Gynecologic Laparoscopes
- 18 Sep Testing Requirements for Healthcare Facility Sterilizers with Non-Traditional Cycle Parameters
- 11 Aug User Instructions for Medical Laser Products: Safety Information and Radiation Hazard Protection Requirements
- 31 Jul Premarket Notification Requirements for Hysteroscopic and Laparoscopic Insufflators
- 25 Jul Preparing 510k Submissions for Medical Exercise Equipment
- 25 Jul Preparing 510k Submissions for Heating and Cooling Therapeutic Devices
- 25 Jul Premarket Notification Requirements for Manual and Powered Wheelchairs and Three-Wheeled Vehicles
- 28 Jun Testing and Labeling Requirements for Non-Latex Male Condoms
- 31 May Content and Format Requirements for Medical Laser 510k Submissions
- 30 Apr Testing of Non-Articulating, Mechanically Locked Modular Implant Components in Orthopedic Devices
- 01 Mar Enforcement Policy for X-Ray Assembly Report Filing Requirements
- 28 Feb Recordkeeping Requirements and Exemptions for Portable Home Sunlamp Products and UV Lamps
- 28 Feb Model and Serial Number Labeling Requirements for X-Ray System Components
- 28 Feb Correction and Reporting Requirements for Diagnostic X-Ray Equipment Defects and Noncompliances
- 28 Feb Applicability of Sunlamp Performance Standards to UVA Tanning Products (Revoked)
- 09 Jan Ceramic Ball Hip Systems - Requirements for 510k Premarket Notifications
- 01 Nov 510k Submissions for Mechanical Lithotripters and Stone Dislodgers in Gastroenterology and Urology
- 18 Sep Premarket Notification Requirements for Sterile Lubricating Jelly Used with Transurethral Surgical Instruments
- 11 Sep Premarket Notification Requirements for Conventional and Antimicrobial Foley Catheters with Balloon Retention
- 29 Aug Extended Laparoscopy Devices - Premarket Notification (510k) Submissions
- 25 Jul Cervical Cytology Device Development and Validation Requirements
- 07 Jun Premarket Notification Requirements for Urine Drainage Bags and Accessories
- 27 Apr Testing Requirements for Orthopedic Implants with Modified Metallic Bone-Interface Surfaces
- 23 Feb Regulatory Requirements for Condom-Like Products and Novelty Condoms
- 13 Oct Enforcement Policy for Positive-Beam Limitation Requirements in Diagnostic X-Ray Systems
- 01 Oct Medical Waste Sharps Containers and Secondary Sharps Containers - Design, Testing, and Labeling Requirements
- 30 Sep Premarket Notification Requirements for Aerosol Delivery Devices: Nebulizers, Metered Dose Inhalers, Spacers and Actuators
- 01 Aug Surgical Gowns and Surgical Drapes - Performance Testing and Labeling Requirements
- 01 Aug Endoscope Washers and Washer/Disinfectors - 510k Review Requirements
- 07 Jun Beam Attenuator and Emission Indicator Requirements for Class II and IIIa Visible Laser Systems
- 10 May Electromagnetic Compatibility Testing and Safety Requirements for Powered Wheelchairs
- 31 Mar Piston Syringes and Accessories - Review Requirements and Testing Specifications for 510k Submissions
- 31 Mar 510k Requirements for Hypodermic Single Lumen Needles
- 01 Mar Premarket Notification Requirements for Healthcare Facility Sterilizers
- 28 Feb Clinical Electronic Thermometers - Review Requirements and Testing Specifications
- 09 Feb Ureteral Stents - Content and Testing Requirements for 510k Submissions
- 09 Feb Premarket Notification Requirements for Gastroenterology and Urology Biopsy Devices
- 01 Jun Laser Products - Performance Standards and Safety Requirements
- 15 May In Vitro Diagnostic Devices for Detection of Parvovirus B19 Antibodies in Human Serum and Plasma
- 01 Apr Shelf Life and Stability Testing for Medical Devices
- 07 Mar Device Labeling Requirements and Content for Premarket Approval Applications
- 01 Feb Quality Assurance Guidelines for Hemodialysis Devices and Facilities
- 01 Sep Labeling Requirements and Recommendations for Medical Devices
- 30 Aug Reinspection of Firms During Pending Legal Actions
- 01 Mar Radiation Control Requirements and Interpretations for Diagnostic X-ray Equipment
- 01 Mar Diagnostic X-Ray Systems: Component Labeling, Assembly, and Safety Requirements
- 28 Feb Radiation Safety Requirements for Diagnostic X-Ray Systems and Components
- 01 Feb Requirements for 510k Submissions for Oxygen Conserving Devices
- 01 Mar Quality Control and Quality Assurance for Sunlamp Products and UV Lamps
- 01 Mar Calibration Constancy Intercomparison System for Microwave Oven Survey Instruments
- 01 Jun Device Master Files - Content, Format, and Submission Requirements
- 01 Jun Color Additives in Medical Devices: Requirements for Direct Body Contact Applications
- 21 Oct Classification of Large Laser-Based Materials Processing Machines with Walk-In Workstations
- 05 Feb Reproduction of Hazard Warning Labels in User Instructions for Laser Products with Cosmetic Enclosures
- 20 Jan Safety Requirements for Medical Laser Delivery Systems and Interlock Mechanisms
- 16 Sep Exemptions from Reporting Requirements for Limited Production of Sunlamp Products for Commercial Use
- 18 May Significant Risk Determination for Investigational Medical Laser Devices
- 30 Sep X-ray Field Size Control Requirements for Fluoroscopic and Spot-Film Systems
- 25 Aug Alternative Warning Statements for Laser Product User Information
- 01 May Quality Control Practices for Mercury Vapor Lamp Manufacturing and Testing
- 23 Nov Laser Light Shows and Demonstration Laser Products: Performance Standards and Manufacturer Requirements
- 02 Mar Warning Label Requirements for Multiple Wavelength and Dye Laser Products
- 01 Jan Emergency Use Oxygen Generators and Oxygen Equipment: Flow Rate and Distribution Requirements
- 23 Nov In-House Manufactured Laser Products: Applicability of Federal Performance Standards
- 14 Oct Laser Products Sold in Kit Form: Identification, Certification and Compliance Requirements
- 07 Oct Remote Interlock Connector Requirements for Laser Products
- 05 Aug Viewing Optics Performance Requirements for Surveying Laser Products