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Code of Federal Regulations Title 21. Food and Drugs § 21.822.7 What should I do if I do not agree that postmarket surveillance is appropriate?

Current as of January 02, 2025 | Updated by Findlaw Staff

(a) If you do not agree with our decision to order postmarket surveillance for a particular device, you may request review of our decision by:

(1) Requesting a meeting with the individual who issued the order for postmarket surveillance;

(2) Seeking internal review of the order under § 10.75 of this chapter;

(3) Requesting an informal hearing under part 16 of this chapter;  or

(4) Requesting review by the Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee.

(b) You may obtain guidance documents that discuss these mechanisms from the Center for Devices and Radiological Health's (CDRH's) Web site (http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHOmbudsman/default.htm).

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.822.7 What should I do if I do not agree that postmarket surveillance is appropriate? - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-822-7/

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