21 CFR 822.11
§ 822.11 What should I consider when designing my plan to conduct postmarket surveillance?
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 822.11, § 822.11 What should I consider when designing my plan to conduct postmarket surveillance?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88932
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Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.