---
kind: "section"
citation: "21 C.F.R. § 860.120"
title: "21"
number: "860.120"
heading: "General."
url: "https://uscodex.org/cfr/21/860.120"
---

# §860.120. General.

- (a) Sections [513(e)](/cfr/21/513.md?p=e) and [(f)](/cfr/21/513.md?p=f), [514(b)](/cfr/21/514.md?p=b), [515(b)](/cfr/21/515.md?p=b), and [520(l)](/cfr/21/520.md?p=l) of the Federal Food, Drug, and Cosmetic Act provide for reclassification of a device and prescribe the procedures to be followed to effect reclassification. The purposes of [subpart C](/cfr/21/subpartC.md) are to:
  - (1) Set forth the requirements as to form and content of petitions for reclassification;
  - (2) Describe the circumstances in which each of the five statutory reclassification provisions applies; and
  - (3) Explain the procedure for reclassification prescribed in the five statutory reclassification provisions.
- (b) The criteria for determining the proper class for a device are set forth in [§ 860.3(c)](/cfr/21/860.3.md?p=c). The reclassification of any device within a generic type of device causes the reclassification of all devices within that generic type. Accordingly, a petition for the reclassification of a specific device will be considered a petition for reclassification of all devices within the same generic type.
- (c) Any interested person may submit a petition for reclassification under section [513(e)](/cfr/21/513.md?p=e), [514(b)](/cfr/21/514.md?p=b), or [515(b)](/cfr/21/515.md?p=b) of the Federal Food, Drug, and Cosmetic Act. A manufacturer or importer may submit a petition for reclassification under section [513(f)](/cfr/21/513.md?p=f) or [520(l)](/cfr/21/520.md?p=l) of the Federal Food, Drug, and Cosmetic Act. The Commissioner may initiate the reclassification of a device under the following sections of the Federal Food, Drug, and Cosmetic Act:
  - (1) [Section 513(e)](/cfr/21/513.md?p=e) (for a classified device other than a device classified into class III under section [513(f)(1)](/cfr/21/513.md?p=f-1) or [520(l)(1)](/cfr/21/520.md?p=l-1) of the Federal Food, Drug, and Cosmetic Act);
  - (2) [Section 513(f)(3)](/cfr/21/513.md?p=f-3) (for a device classified into class III under [section 513(f)(1)](/cfr/21/513.md?p=f-1) of the Federal Food, Drug, and Cosmetic Act); or
  - (3) [Section 520(l)(2)](/cfr/21/520.md?p=l-2) (for a device classified into class III under [section 520(l)(1)](/cfr/21/520.md?p=l-1) of the Federal Food, Drug, and Cosmetic Act).

## Notes

### Amendments

[43 FR 32993, July 28, 1978, as amended at 57 FR 58404, Dec. 10, 1992; 83 FR 64456, 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 57 FR 58404, Dec. 10, 1992; 83 FR 64456, Dec. 17, 2018]