---
kind: "section"
citation: "21 C.F.R. § 822.1"
title: "21"
number: "822.1"
heading: "What does this part cover?"
url: "https://uscodex.org/cfr/21/822.1"
---

# §822.1. What does this part cover?


This part implements [section 522](/cfr/21/522.md) of the Federal Food, Drug, and Cosmetic Act by providing procedures and requirements for postmarket surveillance of class II and class III devices that meet any of the following criteria:

- (a) Failure of the device would be reasonably likely to have serious adverse health consequences;
- (b) The device is intended to be implanted in the human body for more than 1 year;
- (c) **The device is intended to be used outside a user facility to support or sustain life.** If you fail to comply with requirements that we order under [section 522](/cfr/21/522.md) of the Federal Food, Drug, and Cosmetic Act and this part, your device is considered misbranded under [section 502(t)(3)](/cfr/21/502.md?p=t-3) of the Federal Food, Drug, and Cosmetic Act and you are in violation of [section 301(q)(1)(C)](/cfr/21/301.md?p=q-1-C) of the Federal Food, Drug, and Cosmetic Act; or
- (d) **The device is expected to have significant use in pediatric populations.**

## Notes

### Amendments

[67 FR 38887, June 6, 2002, as amended at 88 FR 16880, Mar. 21, 2023]

### Authority

Authority: 21 U.S.C. 331, 352, 360i, 360l, 371, 374.

### Source

Source: 67 FR 38887, June 6, 2002, unless otherwise noted.

### Amendments

[67 FR 38887, June 6, 2002, as amended at 88 FR 16880, Mar. 21, 2023]