21 CFR 822.22
§ 822.22 What recourse do I have if I do not agree with your decision?
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 822.22, § 822.22 What recourse do I have if I do not agree with your decision?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88944
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Full text
(a) If you disagree with us about the content of your plan or if we disapprove your plan, or if you believe there is a less burdensome approach that will answer the surveillance question, 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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.