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 C - Postmarket Surveillance Plan
  7. 21 CFR § 822.11
21 CFR § 822.11
What should I consider when designing my plan to conduct postmarket surveillance?
June 25, 2020
CFR

You must design your surveillance to address the postmarket surveillance question identified in the order you received. You should consider what, if any, patient protection measures should be incorporated into your plan. You should also consider the function, operating characteristics, and intended use of your device when designing a surveillance approach.

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§ 822.10 What must I include in my surveillance plan?
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§ 822.12 Do you have any information that will help me prepare my submission or design my postmarket surveillance plan?

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