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e-CFR data is current as of March 4, 2021 |
Title 21 → Chapter I → Subchapter H → Part 822 → Subpart C → §822.11 |
Title 21: Food and Drugs
PART 822—POSTMARKET SURVEILLANCE
Subpart C—Postmarket Surveillance Plan
§822.11 What should I consider when designing my plan to conduct postmarket surveillance?
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.