21 CFR 822.7
§ 822.7 What should I do if I do not agree that postmarket surveillance is appropriate?
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 822.7, § 822.7 What should I do if I do not agree that postmarket surveillance is appropriate?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88927
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Full text
(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 Director of the Office that 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.).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.