Postmarket 49
- Notifying Device Supply Disruptions and Manufacturing Discontinuances During Public Health Emergencies
- Content of Premarket Submissions and Lifecycle Management for Artificial Intelligence and Machine Learning-Enabled Medical Devices (DRAFT)
- Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection
- Bioresearch Monitoring Program Inspections: Processes and Procedures for Site Evaluations (DRAFT)
- Use of Real-World Data and Real-World Evidence to Support Medical Device Regulatory Decision-Making (DRAFT)
- Review Process for Denied Export Certificates for Medical Devices
- Clinical Electronic Thermometers - Performance, Safety, and Regulatory Requirements
- Voluntary Improvement Program (VIP) for Medical Device Manufacturers: Participation Requirements and Implementation
- 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
- Computer Software Assurance for Production and Quality System Software (DRAFT)
- Patient-Reported Outcome Instruments in Medical Device Evaluation
- Product Labeling Requirements for Laparoscopic Power Morcellators in Gynecologic Surgery
- Multiple Function Device Products: Policy and Considerations for Functions Not Subject to FDA Review
- Requesting Nonbinding Feedback on Form FDA 483 Inspectional Observations
- Dual 510k and CLIA Waiver by Application for In Vitro Diagnostic Tests
- Changes to Medical Device Definition for Software Functions Under the 21st Century Cures Act
- Benefit-Risk Assessment with Uncertainty in Medical Device Premarket Submissions
- Manufacturing Site Changes for PMA-Approved Medical Devices: When to Submit a Supplement and Documentation Requirements
- Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices
- Sharing Patient-Specific Information from Medical Devices with Patients
- Use of Real-World Data to Generate Evidence for Medical Device Regulatory Decisions
- Postmarket Management of Cybersecurity in Medical Devices
- Benefit-Risk Factors in Medical Device Product Availability, Compliance, and Enforcement Decisions
- Public Notification of Medical Device Emerging Signals: New Safety Information and Adverse Events
- Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
- Labeling Requirements for Permanent Hysteroscopic Tubal Implants for Female Sterilization
- List of Device Types That Require Human Factors Data in Premarket Submissions (DRAFT)
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Balancing Pre-Market and Post-Market Data Collection for PMA Medical Devices
- Distinguishing Between Medical Device Recalls and Device Enhancements
- Including Manufacturer's URL on Electronic Product Labels
- Safety Considerations for Hand-Held X-Ray Equipment: Radiation Protection and Testing Requirements
- Import Surveillance and Detention of Medical Gloves that Fail Water Leak Testing
- Import Surveillance and Detention Process for Condoms Failing Water Leak Testing Requirements
- Container and Closure System Integrity Testing as an Alternative to Sterility Testing for Stability Protocols
- Inspection and Field Testing Requirements for Radiation-Emitting Electronic Products
- Dear Doctor Letters for Implantable Cardioverter Defibrillator Recalls: Content and Format Recommendations
- Reprocessor Identification Requirements for Reprocessed Single-Use Devices
- Hospital Bed System Dimensional and Safety Requirements to Reduce Patient Entrapment
- C-Reactive Protein (CRP) Assays - Premarket Notification 510k Submissions
- Electronic Records and Electronic Signatures - Scope and Application
- Assembly, Installation, Adjustment and Testing Information Requirements for Diagnostic X-Ray Systems
- Sterilization of Convenience Kits: Component Compatibility and Validation Requirements
- Labeling Requirements for Keratomes Used in LASIK Surgery
- Testing Requirements for Metallic Plasma Sprayed Coatings on Orthopedic Implants
- Use of Reporting Site Registration Number for Medical Device Reports (MDR) Instead of Manufacturing Site Number
- Regulatory Requirements for Condom-Like Products and Novelty Condoms
- Enforcement Policy for Positive-Beam Limitation Requirements in Diagnostic X-Ray Systems