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21 CFR Part 822 §822.31, 822.33, 822.35, 822.36, 822.38

Maps to

21 CFR Part 822: §822.31 What records am I required to keep?, §822.33 How long must we keep the records?, §822.35 Can you inspect my manufacturing site or other sites involved in my postmarket surveillance plan?, §822.36 Can you inspect and copy the records related to my postmarket surveillance plan?, §822.38 What reports must I submit to you?

Requirement text

Manufacturers subject to a postmarket surveillance order must maintain specified records and submit interim and final reports as required by the approved plan. Records must include all FDA correspondence, signed investigator agreements, the approved plan with deviation documentation, all data and analyses, and any other FDA-required records. Records must be retained for 2 years after FDA accepts the final report. FDA may inspect the manufacturer site and any other sites involved in the surveillance, and may inspect and copy records within 72 hours of initiating an inspection.

21 CFR § 822.31 — 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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