Statutes, codes, and regulations
Code of Federal Regulations
Title 21 - FOOD AND DRUGSChapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubchapter H - MEDICAL DEVICESPart 822 - POSTMARKET SURVEILLANCE
Subpart B - NOTIFICATION
Section 822.6 - When will you notify me that I am required to conduct postmarket surveillance?

21 C.F.R. § 822.6

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Current through March 31, 2024
Section 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.

21 C.F.R. § 822.6