21 C.F.R. § 822.6 When will you notify me that I am required to conduct postmarket surveillance?
Title 21 - Food and Drugs
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.
Title 21: Food and Drugs
PART 822—POSTMARKET SURVEILLANCE
Subpart B—Notification
§ 822.6 When will you notify me that I am required to conduct postmarket surveillance?

