§ 822.1 - What does this part cover?

§ 822.1 What does this part cover?

This part implements section 522 of the Federal Food, Drug, and Cosmetic Act (the 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; or

(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 of the act and Federal Food, Drug, and Cosmetic Act and this part, your device is considered misbranded under section 502(t)(3) of the act and Federal Food, Drug, and Cosmetic Act and you are in violation of section 301(q)(1)(C) of the act. Federal Food, Drug, and Cosmetic Act; or

(d) The device is expected to have significant use in pediatric populations.

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