Section 522 Postmarket Surveillance
FDA's authority to order manufacturers to conduct post-market surveillance studies on certain Class II or Class III devices.
Definition
Section 522 of the Federal Food, Drug, and Cosmetic Act gives FDA authority to require manufacturers to conduct post-market surveillance of Class II or Class III devices when the device meets one of four conditions: failure of the device would be reasonably likely to have serious adverse health consequences; the device is expected to have significant use in pediatric populations; the device is intended to be implanted in the body for more than one year; or the device is intended to be a life-sustaining or life-supporting device used outside a device-user facility. FDA issues a Section 522 order specifying the surveillance question, study design expectations, and timing.What this means in practice
Section 522 orders are the FDA tool for generating real-world evidence on questions left open at clearance, long-term implant performance, rare adverse events, pediatric outcomes, or post-market changes in user environments. Manufacturers must respond to an order within 30 days with a proposed plan and within 15 months begin surveillance. Failure to comply has significant consequences including misbranding determinations. The 522 study list is published and updated regularly by FDA.- •Treating a 522 order as a clinical study like an IDE, 522 surveillance is post-market and the study design questions are different (often registry-based or real-world data).
- •Missing the 30-day plan deadline, FDA can take enforcement action for non-response.
- •Designing a 522 study without engaging the sponsor's medical and statistical teams early, 522 questions are often hard to answer without large real-world data sources.
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsFDA mechanism for receiving reports of device-related deaths, serious injuries, and malfunctions.
Proactive collection of clinical data on a CE-marked device to confirm safety and performance.
Activities to monitor device safety and performance after market release.
FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
More in Post-Market
· Same categoryExpedited FDA MDR for events requiring remedial action to prevent unreasonable risk of substantial harm.
Yearly report required for Class III PMA devices summarizing changes, complaints, and post-approval study status.
Communication to users notifying them of a safety issue, corrective action, or important product information.
FDA's mandatory electronic submission system for Medical Device Reports.
Primary references
3 sources- 1
Section 522 Postmarket Surveillance Studies ProgramVerifiedFDAfda.gov
- 2
21 CFR Part 822VerifiedeCFRecfr.gov
- 3
FDA Recalls - Medical DevicesVerifiedFDAfda.gov
Inline markers like [1] jump to the matching reference above.