21 CFR 806.30

§ 806.30 FDA access to records.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 806.30, § 806.30 FDA access to records, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88735
Permanent ID: ys:prov:88735@1
SHA-256: f5e9e9d7366dbab21a1b6d73e6a62a7e337298eab15b800639b07d943215ffeb

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Full text

Each device manufacturer or importer required under this part to maintain records and every person who is in charge or custody of such records shall, upon request of an officer or employee designated by FDA and under section 704(e) of the act, permit such officer or employee at all reasonable times to have access to, and to copy and verify, such records and reports.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.