---
kind: "section"
citation: "21 C.F.R. § 807.94"
title: "21"
number: "807.94"
heading: "Format of a class III certification."
url: "https://uscodex.org/cfr/21/807.94"
---

# §807.94. Format of a class III certification.

- (a) A class III certification submitted as part of a premarket notification shall state as follows:
- (b) The statement in [paragraph (a)](#a) of this section should be signed by the certifier, clearly identified as “class III certification,” and included at the beginning of the section of the premarket notification submission that sets forth the class III summary.

## Notes

### Amendments

[59 FR 64296, Dec. 14, 1994]

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360e-4, 360i, 360j, 360bbb-8b, 371, 374, 379k-1, 381, 393; 42 U.S.C. 264, 271.

### Source

Source: 42 FR 42526, Aug. 23, 1977, unless otherwise noted.

### Amendments

[59 FR 64296, Dec. 14, 1994]