21 CFR 822.6
§ 822.6 When will you notify me that I am required to conduct postmarket surveillance?
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 822.6, § 822.6 When will you notify me that I am required to conduct postmarket surveillance?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88926
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Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.