U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 29, 2025

§ 822.6 - When will you notify me that I am required to conduct postmarket surveillance?

We will notify you as soon as we have determined that postmarket surveillance of your device is necessary, based on the identification of a surveillance question. This may occur during the review of a marketing application for your device, as your device goes to market, or after your device has been marketed for a period of time.