21 CFR §822.6
Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
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.