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Code of Federal Regulations Title 21. Food and Drugs § 21.822.4 Does this part apply to me?

Current as of January 02, 2025 | Updated by Findlaw Staff

If we have ordered you to conduct postmarket surveillance of a medical device under section 522 of the 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;  or

(c) The device is intended to be used to support or sustain life and to be used outside a user facility.

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.822.4 Does this part apply to me? - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-822-4/

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