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21 CFR Part 822 §822.28

Maps to

21 CFR Part 822: §822.28 If I stop marketing the device subject to postmarket surveillance, what must I do?

Requirement text

A manufacturer subject to a postmarket surveillance order must continue to conduct the surveillance in accordance with the approved plan even if it stops marketing the device. The manufacturer may request FDA permission to terminate or modify the surveillance because it is no longer marketing the device, but FDA evaluates such requests on a case-by-case basis. The manufacturer must continue the surveillance until FDA specifically notifies the manufacturer that it may stop.

21 CFR § 822.28 — 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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