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522 Post-Market Surveillance Studies

US-unique

The § 522 post-market surveillance study order is a US-specific FDA tool. FDA can compel manufacturers to conduct post-market studies for specific device types.

Authority​

Under FD&C Act § 522 [21 U.S.C. § 360l], FDA may order a manufacturer to conduct post-market surveillance of a Class II or III device if:

  • The device's failure would be reasonably likely to have serious adverse health consequences
  • The device is intended to be implanted for more than 1 year
  • The device is intended to be used outside of a user facility to support or sustain life

How a 522 order is issued​

FDA identifies devices for potential § 522 orders through analysis of MDR data, post-approval study results, and other post-market information. FDA notifies the manufacturer and provides an opportunity to respond before issuing a formal order.

Study requirements​

A § 522 study plan must be submitted within 30 days of receiving the order (or a longer period if FDA specifies). The study plan must include:

  • Study design and methodology
  • Endpoints and sample size justification
  • Timeline for completion
  • Data collection and analysis plan

Reporting​

§ 522 study progress reports are typically required annually. Final study results are submitted to FDA upon study completion and may be published in the FDA database.

Official resources​