---
kind: "section"
citation: "21 C.F.R. § 861.1"
title: "21"
number: "861.1"
heading: "Purpose and scope."
url: "https://uscodex.org/cfr/21/861.1"
---

# §861.1. Purpose and scope.

- (a) This part implements [section 514](/cfr/21/514.md) of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the establishment, amendment, and revocation of performance standards applicable to devices intended for human use.
- (b) The Food and Drug Administration may determine that a performance standard, as described under special controls for class II devices in [§ 860.7(b)](/cfr/21/860.7.md?p=b) of this chapter, is necessary to provide reasonable assurance of the safety and effectiveness of the device. Performance standards may be established for:
  - (1) A class II device;
  - (2) A class III device which, upon the effective date of the standard, is reclassified into class II; and
  - (3) A class III device, as a condition to premarket approval under [section 515](/cfr/21/515.md) of the act, to reduce or eliminate a risk or risks associated with such device.
- (c) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.

## Notes

### Amendments

[45 FR 7484, Feb. 1, 1980, as amended at 45 FR 23686, Apr. 8, 1980; 57 FR 58404, Dec. 10, 1992]

### Authority

Authority: 21 U.S.C. 351, 352, 360c, 360d, 360gg-360ss, 371, 374; 42 U.S.C. 262, 264.

### Source

Source: 45 FR 7484, Feb. 1, 1980, unless otherwise noted.

### Amendments

[45 FR 7484, Feb. 1, 1980, as amended at 45 FR 23686, Apr. 8, 1980; 57 FR 58404, Dec. 10, 1992]