Procedures when the Commissioner initiates a performance standard or premarket approval proceeding under section 514(b) or 515(b) of the Federal Food, Drug, and Cosmetic Act.
21 C.F.R. § 860.132
in effectEffective: 2024-07-01(a) Sections 514(b) and 515(b) of the Federal Food, Drug, and Cosmetic Act require the Commissioner to provide, by notice in the Federal Register, an opportunity for interested parties to petition to change the classification of a device based upon new information relevant to its classification when the Commissioner initiates a proceeding to develop a performance standard for the device if in class II or to issue an order requiring premarket approval for the device if in class III.
(b) If the Commissioner agrees that the new information submitted in response to a proposed order to require premarket approval of a device issued under section 515(b) of the Federal Food, Drug, and Cosmetic Act warrants a change in classification, the Commissioner shall follow the administrative order procedures under section 513(e) of the Federal Food, Drug, and Cosmetic Act and § 860.130 to effect such a change.
(c) If the Commissioner does not agree that the new information submitted in response to a proposed order to require premarket approval of a device issued under section 515(b) of the Federal Food, Drug, and Cosmetic Act warrants a change in classification, the Commissioner will deny the petition.
(d) The procedures under section 514(b) of the Federal Food, Drug, and Cosmetic Act are as follows:
(1) Within 30 days after publication of the Commissioner's notice referred to in paragraph (a) of this section, an interested person files a petition for reclassification in accordance with § 860.123.
(2) The Commissioner consults with the appropriate classification panel with regard to the petition in accordance with § 860.125.
(3) Within 60 days after publication of the notice referred to in paragraph (a) of this section, the Commissioner either denies the petition or gives notice of the intent to initiate a change in classification in accordance with § 860.130.
Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-21.xmlFetched: 7/26/2026