21 C.F.R. § 822.6   When will you notify me that I am required to conduct postmarket surveillance?


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 822—POSTMARKET SURVEILLANCE
Subpart B—Notification

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§ 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.

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