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 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.Examples
- Illustrative: A manufacturer of a new cardiovascular implantable device receives a Section 522 order to conduct a post-market study evaluating the long-term integrity and performance of the device in a broad patient population.
- Illustrative: For a novel pediatric respiratory support device, the FDA issues a Section 522 order to gather real-world evidence on its effectiveness and safety outcomes when used in diverse pediatric age groups over time.
- Illustrative: A manufacturer of a life-sustaining external device intended for home use receives a Section 522 order to investigate user-related errors and device performance in uncontrolled environments after market entry.
- •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.
Frequently asked questions
Related terms
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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.
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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.
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Sources
4 sourcesSources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
Official-source claim check:
Section 522 applies to specified class II and III devices; a plan is due within 30 days of receipt and surveillance must begin within 15 months of order issuance.
Partial review: verified corrections are applied, but this is not a full accuracy certification. The last full review date is unchanged.
Remaining verification limits
- Original merged record reviewed in full. Illustrative examples are hypothetical, not verified case histories. Evidence supports the specific propositions below, not an assertion that every linked page verifies all merged content.
- 121 CFR Part 822Tier 1 VerifiedeCFRecfr.gov
- 2FDA Recalls - Medical DevicesTier 2 VerifiedFDAfda.gov
- 3EUDAMED Public SiteTier 2 VerifiedEuropean Commissionec.europa.eu
- 4FDA October 2022 section 522 guidanceTier 2 UncheckedFDAfda.gov
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