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e-CFR data is current as of March 4, 2021 |
Title 21 → Chapter I → Subchapter H → Part 822 → Subpart B → §822.6 |
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?
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.