21 CFR § 806.30 - FDA access to records.

---
identifier: "/us/cfr/t21/s806.30"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 806.30 - FDA access to records."
title_number: 21
title_name: "Food and Drugs"
section_number: "806.30"
section_name: "FDA access to records."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "806"
part_name: "MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 352, 360, 360i, 360j, 371, 374."
regulatory_source: "62 FR 27191, May 19, 1997, unless otherwise noted."
cfr_part: "806"
---


# 806.30 FDA access to records.

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.

[63 FR 42233, Aug. 7, 1998]