Post-Approval Studies for Medical Devices: Protocol Development, Tracking and Reporting Requirements
This guidance outlines procedures for handling Post-Approval Studies (PAS) imposed as conditions of PMA approval. It provides recommendations on protocol development, reporting requirements, study status tracking, and public disclosure of PAS information. The guidance aims to help stakeholders understand PAS requirements and facilitate timely completion of studies.
Recommended Actions
- Develop comprehensive PAS protocol including all recommended elements
- Submit protocol within required timeframe (30 days if not approved with PMA)
- Establish tracking system for enrollment milestones and reporting deadlines
- Submit enrollment status reports until enrollment completion
- Submit progress reports every 6 months until enrollment completion, then annually
- Notify FDA promptly of any challenges meeting milestones or requirements
- Submit final report within 3 months of study completion
- Maintain documentation of protocol adherence and study progress
- Monitor for safety signals and report any concerns promptly
- Prepare for public disclosure of study information on FDA website
Key Considerations
Clinical testing
- Study protocol must include clear objectives, endpoints, population description, and follow-up schedule
- Enrollment milestones recommended:
- First subject within 6 months of protocol approval
- 20% enrolled within 12 months
- 50% enrolled within 18 months
- 100% enrolled within 24 months
Safety
- Safety concerns identified during PAS may lead to FDA actions including Safety Communications
- Summary of safety data required in progress and final reports
Other considerations
- Protocol must be submitted within 30 days of PMA approval if not approved at time of PMA
- Progress reports required every 6 months until enrollment completion, then annually
- Final report due within 3 months of study completion
- Public disclosure of PAS information on FDA website
- Early communication with FDA recommended if barriers to study completion arise
Relevant Guidances
- Balancing Pre-Market and Post-Market Data Collection for PMA Medical Devices
- Annual Reports for PMA-Approved Medical Devices: Content, Format and Submission Requirements
- Modifications to PMA-Approved Class III Medical Devices: Selecting the Appropriate Regulatory Submission Type
- Real-Time Review Process for Minor Changes to Approved Medical Devices through PMA Supplements
- Manufacturing Site Inspections and PMA Review Process for Medical Devices
Related references and norms
- 21 CFR 814.82: Post-approval requirements
- 21 CFR 814.39: PMA supplements and amendments
- 21 CFR 814.9: Confidentiality of data and information in PMA files
- 21 CFR Part 20: Public information
Original guidance
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