Postmarket Surveillance Studies Requirements for Medical Devices Under Section 522
This guidance outlines FDA's authority to require manufacturers to conduct postmarket surveillance for certain class II or class III devices, either at approval/clearance or afterward. It details the process, requirements, and responsibilities for implementing and reporting postmarket surveillance under section 522 of the FD&C Act.
Recommended Actions
- Develop and submit surveillance plan within 30 days of receiving 522 order
- Obtain FDA approval of plan before initiating surveillance
- Implement enrollment tracking system to meet recommended milestones
- Establish data collection and quality control procedures
- Set up regular reporting schedule (6-month intervals initially, then annual)
- Monitor study progress against approved timelines
- Communicate promptly with FDA regarding any delays or challenges
- Maintain complete documentation of all surveillance activities
- Submit final report within 3 months of study completion
- Ensure compliance with public disclosure requirements
Key Considerations
Clinical testing
- Must commence surveillance within 15 months of order issuance
- Recommended enrollment milestones:
- 20% enrolled within 18 months
- 50% enrolled within 21 months
- 100% enrolled within 24 months
- Must submit interim reports every 6 months for first 2 years, then annually
- Final report due within 3 months of study completion
- Must include subject accountability, safety/effectiveness data
- Must address diversity in sex, age, race and ethnicity when applicable
Non-clinical testing
- Data accrual milestone reports required to track progress
- Final report due within 3 months of last datapoint capture
Safety
- Must report adverse events and complications
- Must assess relatedness of endpoints with device/procedure
- Must provide post-mortem examination reports for deaths
Other considerations
- Must submit surveillance plan within 30 days of order receipt
- Plan must include objectives, methodology, sample size, data collection procedures
- Changes affecting data validity require FDA approval
- Failure to comply may result in enforcement actions
- Results may be publicly disclosed on FDA website
- Pediatric studies must comply with ClinicalTrials.gov requirements
Relevant Guidances
- Collection and Reporting of Race and Ethnicity Data in Clinical Trials
- Sex-Specific Considerations in Medical Device Clinical Studies: Patient Enrollment, Data Analysis and Reporting
- Certifying Compliance with Clinical Trial Registration Requirements on Form FDA 3674
- Design Considerations for Medical Device Pivotal Clinical Studies
Related references and norms
- 21 CFR Part 822: Postmarket Surveillance
- 21 CFR Part 10.75: Internal Agency Review of Decisions
- 21 CFR Part 16: Regulatory Hearing before the Food and Drug Administration
Original guidance
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