FDA Guidance on Post-Approval Studies for PMA Medical Devices (2022 Update) (fda.gov)

• Issued October 7, 2022, supersedes 2009 version.
• Recommends enrollment milestones: 100% within 24 months.
• Encourages real-world data and least burdensome methods.
• Publicly accessible via PAS Database and advisory panels.

"The U.S. Food and Drug Administration published a final guidance document on October 7, 2022, updating procedures for post-approval studies (PAS) required as conditions of premarket approval (PMA) for medical devices. The guidance details protocol development, submission, reporting, and study status definitions. It recommends enrollment milestones: first subject within 6 months, 20% enrollment by 12 months, 50% by 18 months, 100% by 24 months from protocol approval. The document encourages least burdensome approaches and use of real-world data. It supersedes the 2009 version and aims to improve timely collection of postmarket data."