21 CFR 822.5
§ 822.5 How will I know if I must conduct postmarket surveillance?
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 822.5, § 822.5 How will I know if I must conduct postmarket surveillance?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88925
- Permanent ID
ys:prov:88925@1- SHA-256
eb2023a4ac716f0b9f8da62fd70a2c2dda61a4c300ed4d9110dd9e5bda9420e5
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
We will send you a letter (the postmarket surveillance order) notifying you of the requirement to conduct postmarket surveillance. Before we send the order, or as part of the order, we may require that you submit information about your device that will allow us better to define the scope of a surveillance order. We will specify the device(s) subject to the surveillance order and the reason that we are requiring postmarket surveillance of the device under section 522 of the act. We will also provide you with any general or specific guidance that is available to help you develop your plan for conducting postmarket surveillance.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.