Maps to
21 CFR Part 806: §806.30 FDA access to records.
Requirement text
Every device manufacturer or importer required under this part to maintain records, and every person who is in charge or custody of such records, must, upon request of an officer or employee designated by FDA and under section 704(e) of the Federal Food, Drug, and Cosmetic Act, permit that officer or employee at all reasonable times to have access to, and to copy and verify, such records and reports.