21 CFR § 822.4 - Does this part apply to me?
If we have ordered you to conduct postmarket surveillance of a medical device under section 522 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.