21 C.F.R. § 17.51

Judicial review

Read at: eCFRecfr.gov CornellLII GovInfogovinfo.gov CasesGoogle Scholar

(a) The final decision of the Commissioner of Food and Drugs or other entity deciding the appeal (currently the DAB) constitutes final agency action from which a respondent may petition for judicial review under the statutes governing the matter involved. Although the filing of a petition for judicial review does not stay a decision under this part, a respondent may file a petition for stay of such decision under § 10.35 of this chapter.

(b) The Chief Counsel of FDA has been designated by the Secretary of Health and Human Services as the officer on whom copies of petitions for judicial review are to be served. This officer is responsible for filing the record on which the final decision is based. The record of the proceeding is certified by the entity deciding the appeal (currently the DAB).

(c) Exhaustion of an appeal to the entity deciding the appeal (currently the DAB) is a jurisdictional prerequisite to judicial review.

Notes of Decisions

Cited in 2 cases (1 in the last 5 years), 2009–2025 · leading case: TMJ Implants, Inc. v. United States Dep't of Health & Human Servs., 584 F.3d 1290 (10th Cir. 2009).

Sort: Relevance Newest Treatment

TMJ Implants, Inc. v. United States Dep't of Health & Human Servs., 584 F.3d 1290 (10th Cir. 2009). “” 21 C.F.R. § 17.51 . Under 21 U.S.C. § 333 (f)(6), petitioners may petition for judicial review directly in this court.”

Vape Cent. Grp., LLC v. Food & Drug Admin. (D.D.C. 2025). “§ 333 (f)(6); 21 C.F.R. § 17.51 . Notably, an aggrieved party is not required to pay any civil penalties assessed by the agency until after judicial review is complete.”

Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.