---
kind: "section"
citation: "21 C.F.R. § 822.4"
title: "21"
number: "822.4"
heading: "Does this part apply to me?"
url: "https://uscodex.org/cfr/21/822.4"
---

# §822.4. Does this part apply to me?


If we have ordered you to conduct postmarket surveillance of a medical device under [section 522](/cfr/21/522.md) of the Federal Food, Drug, and Cosmetic Act, this part applies to you. We have the authority to order postmarket surveillance of any class II or class III medical device, including a device reviewed under the licensing provisions of section 351 of the Public Health Service Act, that meets 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 to support or sustain life and to be used outside a user facility; 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]