§ 822.28 If I stop marketing the device subject to postmarket surveillance, what must I do?

You must continue to conduct postmarket surveillance in accordance with your approved plan even if you no longer market the device. You may request that we allow you to terminate postmarket surveillance or modify your postmarket surveillance because you no longer market the device. We will make these decisions on a case-by-case basis, and you must continue to conduct the postmarket surveillance unless we notify you that you may stop your surveillance study.

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FDA guidance that cites § 822.28

• Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff 7 Oct 2022

Amendment history

Federal Register documents that created or amended this section.

• 67 FR 38887 6 Jun 2002