---
kind: "section"
citation: "21 C.F.R. § 860.132"
title: "21"
number: "860.132"
heading: "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."
url: "https://uscodex.org/cfr/21/860.132"
---

# §860.132. 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.

- (a) Sections [514(b)](/cfr/21/514.md?p=b) and [515(b)](/cfr/21/515.md?p=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)](/cfr/21/515.md?p=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)](/cfr/21/513.md?p=e) of the Federal Food, Drug, and Cosmetic Act and [§ 860.130](/cfr/21/860.130.md) 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)](/cfr/21/515.md?p=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)](#a) of this section, an interested person files a petition for reclassification in accordance with [§ 860.123](/cfr/21/860.123.md).
  - (2) The Commissioner consults with the appropriate classification panel with regard to the petition in accordance with [§ 860.125](/cfr/21/860.125.md).
  - (3) Within 60 days after publication of the notice referred to in [paragraph (a)](#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](/cfr/21/860.130.md).

## Notes

### Amendments

[43 FR 32993, July 28, 1978, as amended at 83 FR 64457, Dec. 17, 2018]

### Authority

Authority: 21 U.S.C. 321(h), 353(g), 360c, 360d, 360e, 360i, 360j, 371, 374.

### Source

Source: 43 FR 32993, July 28, 1978, unless otherwise noted.

### Amendments

[43 FR 32993, July 28, 1978, as amended at 83 FR 64457, Dec. 17, 2018]