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21 CFR Part 806 §806.1, 806.20

Maps to

21 CFR Part 806: §806.1 Scope., §806.20 Records of corrections and removals not required to be reported.

Requirement text

Manufacturers and importers who initiate a correction or removal that is not required to be reported to FDA under 806.10 must still keep a record of that correction or removal. These records must contain specified information about the device, the event giving rise to the action, and the corrective or removal action taken. Records must be retained for 2 years beyond the expected life of the device and must be transferred to any new manufacturer or importer.

21 CFR § 806.1 — 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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