21 CFR 822.24
§ 822.24 What are my responsibilities once I am notified that I am required to conduct postmarket surveillance?
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 822.24, § 822.24 What are my responsibilities once I am notified that I am required to conduct postmarket surveillance?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88947
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Full text
You must submit your plan to conduct postmarket surveillance to us within 30 days from receipt of the order (letter) notifying you that you are required to conduct postmarket surveillance of a device. The manufacturer shall commence surveillance not later than 15 months after the day the order was issued.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.