21 CFR § 860.133 - Procedures when the Commissioner initiates a proceeding to require premarket approval under section 515(b) of the Federal Food, Drug, and Cosmetic Act.

---
identifier: "/us/cfr/t21/s860.133"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 860.133 - Procedures when the Commissioner initiates a proceeding to require premarket approval under section 515(b) of the Federal Food, Drug, and Cosmetic Act."
title_number: 21
title_name: "Food and Drugs"
section_number: "860.133"
section_name: "Procedures when the Commissioner initiates a proceeding to require premarket approval under section 515(b) of the Federal Food, Drug, and Cosmetic Act."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "860"
part_name: "MEDICAL DEVICE CLASSIFICATION PROCEDURES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321(h), 353(g), 360c, 360d, 360e, 360i, 360j, 371, 374."
regulatory_source: "43 FR 32993, July 28, 1978, unless otherwise noted."
cfr_part: "860"
---


# 860.133 Procedures when the Commissioner initiates a proceeding to require premarket approval under section 515(b) of the Federal Food, Drug, and Cosmetic Act.

(a) Section 515(b) of the Federal Food, Drug, and Cosmetic Act applies to proceedings to require premarket approval for a class III preamendments device.

(b) The Commissioner may require premarket approval for a class III preamendments device by administrative order published in the *Federal Register* following publication of a proposed order in the *Federal Register,* a meeting of a device classification panel described in section 513(b) of the Federal Food, Drug, and Cosmetic Act, and consideration of comments from all affected stakeholders, including patients, payors, and providers. The panel will consider reclassification petitions received in the proceeding in accordance with section 513(e) of the Federal Food, Drug, and Cosmetic and the applicable consultation procedures in § 860.125. A recommendation submitted to the Commissioner by the panel will be published in the *Federal Register* when the Commissioner publishes an administrative order under this section.

[83 FR 64457, Dec. 17, 2018]