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    Post-MarketPost-Market & SafetyGlobal MarketsSection 522

    Section 522 Postmarket Surveillance

    FDA's authority to order manufacturers to conduct post-market surveillance studies on certain Class II or Class III devices.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed June 20, 2026

    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 the regulation says
    FD&C Act §522 (21 U.S.C. §360l) and 21 CFR Part 822. FDA publishes the current list of active 522 orders and accepts study plans, status updates, and final reports through CDRH.

    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.
    Common pitfalls
    • •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.

    Primary references

    3 sources
    Link health: 1 verified 2 bot-blocked· last checked 2026-06-20
    FDA·2eCFR·1
    1. 1
      Section 522 Postmarket Surveillance Studies Program
      Bot-blocked
      FDAfda.gov
    2. 2
      21 CFR Part 822
      Verified
      eCFRecfr.gov
    3. 3
      FDA Recalls - Medical Devices
      Bot-blocked
      FDAfda.gov

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