PMA Post-Approval Study Considerations

By Peter Weiman, Director, Clinical Programs

In the United States, the FDA mandates Post-Approval Studies (PAS) to monitor the safety and effectiveness of certain high-risk medical devices approved via the Premarket Approval (PMA) pathway. These studies address residual uncertainties in benefit-risk profiles, ensuring continued regulatory assurance post-market. FDA requires manufacturers to submit PAS protocols, which undergo FDA review within 30 days, emphasizing adherence to predefined milestones, such as subject enrollment and reporting schedules. Typical PAS milestones include enrolling the first subject within six months and achieving 100% enrollment within 24 months.

Ongoing compliance is monitored through interim and final reports, which track enrollment, device performance, safety, and data reliability. Effective PAS execution demands consistent follow-up, robust data collection, and strict protocol adherence. This rigorous process underscores FDA’s commitment to safeguarding public health through comprehensive post-market surveillance of critical medical devices.