CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 806—MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS > SUBPART B—Reports and Records (§806.10 to §806.40) > 806.30—FDA access to records.

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.

Code of Federal Regulations

[63 FR 42233, Aug. 7, 1998]