Post-Market
Section 522 Postmarket Surveillance(Section 522)
In one line
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.
Why it matters
Section 522 surveillance answers device-specific postmarket safety or effectiveness questions using an appropriate study design. Submit a proposed surveillance plan within 30 days after receiving the order, and begin surveillance within 15 months after FDA issues the order. Noncompliance may render the device misbranded.
Common pitfalls
- •Do not assume section 522 surveillance must use a registry or cannot involve a clinical investigation. Choose a design responsive to the surveillance question and assess applicable human-subject and IDE requirements.
- •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.
Sources
- 21 CFR Part 822 · eCFR
- FDA Recalls - Medical Devices · FDA
- EUDAMED Public Site · European Commission
- FDA October 2022 section 522 guidance · FDA