21 CFR 822.4 - Does this part apply to me?
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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:
Title 21 published on 2014-04-01
no entries appear in the Federal Register after this date.