You must submit your plan to conduct postmarket surveillance to us within 30 days from receipt of the order (letter) notifying you that you are required to conduct postmarket surveillance of a device. The manufacturer shall commence surveillance not later than 15 months after the day the order was issued.
21 CFR Part 822 · Postmarket Surveillance
§ 822.24 What are my responsibilities once I am notified that I am required to conduct postmarket surveillance?
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
Amendment history
Federal Register documents that created or amended this section.
- 88 FR 16880 21 Mar 2023