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21 CFR Part 822 §822.34

Maps to

21 CFR Part 822: §822.34 What must I do with the records if the sponsor of the plan or an investigator in the plan changes?

Requirement text

When the sponsor of a postmarket surveillance plan or an investigator in the plan changes, the manufacturer must ensure that all records related to the postmarket surveillance are transferred to the new sponsor or investigator. FDA must be notified within 10 working days of the effective date of the change. The notification must provide the name, address, and telephone number of the new sponsor or investigator, certify that all records have been transferred, and provide the date of transfer.

21 CFR § 822.34 — 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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