21 CFR 822.32
§ 822.32 What records are the investigators in my surveillance plan required to keep?
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 822.32, § 822.32 What records are the investigators in my surveillance plan required to keep?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88957
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Full text
Your investigator must keep copies of:
(a) All correspondence between investigators, FDA, the manufacturer, and the designated person, including required reports.
(b) The approved postmarket surveillance plan, with documentation of the date and reason for any deviation from the plan.
(c) All data collected and analyses conducted at that site for postmarket surveillance.
(d) Any other records that we require to be maintained by regulation or by order.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.