eCFR Reference Browser

---

title: "21 CFR §806.30"

source: "https://www.ecfr.gov/current/title-21/section-806.30"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "806"

part_subject: "MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS"

subpart_code: "B"

subpart_subject: "Reports and Records"

section_number: "806.30"

section_subject: "FDA access to records."

cfr_reference: "21 CFR 806.30"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

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.

§806.30 - FDA access to records.