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21 CFR Part 822 §822.26

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21 CFR Part 822: §822.26 If my company changes ownership, what must I do?

Requirement text

When a company subject to a postmarket surveillance order undergoes a change in ownership, the manufacturer must notify FDA within 30 days of the change. The notification should identify any changes to the company's name or address, the contact person, or the designated person as defined in §822.3(b). The obligation to conduct postmarket surveillance generally transfers to the new owner; however, if both parties agree that the original manufacturer will continue the surveillance, that arrangement is permissible — but the original manufacturer must still notify FDA of the ownership change.

21 CFR § 822.26 — 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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