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21 CFR Part 806 §806.30

Maps to

21 CFR Part 806: §806.30 FDA access to records.

Requirement text

Every device manufacturer or importer required to maintain corrections and removals records, and every person in charge or custody of such records, must permit, upon request of an authorized FDA officer or employee, access to, and the right to copy and verify, those records and reports at all reasonable times.

21 CFR § 806.30 — current eCFR →

Related clauses

MDR Reporting Requirements — General ObligationsWritten MDR ProceduresMDR Event Files and Records RetentionManufacturer MDR Reporting — Adverse Event Investigation and Submission5-Day Expedited MDR ReportsReports of Corrections and Removals

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