1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 822 - POSTMARKET SURVEILLANCE
  6. Subpart B - Notification
  7. 21 CFR § 822.6
21 CFR § 822.6
When will you notify me that I am required to conduct postmarket surveillance?
June 25, 2020
CFR

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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§ 822.5 How will I know if I must conduct postmarket surveillance?
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§ 822.7 What should I do if I do not agree that postmarket surveillance is appropriate?

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