21 CFR 822.15
§ 822.15 How long must I conduct postmarket surveillance of my device?
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 822.15, § 822.15 How long must I conduct postmarket surveillance of my device?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88936
- Permanent ID
ys:prov:88936@1- SHA-256
965978c781df5fea511edc4b9120677cec382af0f070c7a4ceb2d43196cdc2af
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
The length of postmarket surveillance will depend on the postmarket surveillance question identified in our order. We may order prospective surveillance for a period up to 36 months; longer periods require your agreement. If we believe that a prospective period of greater than 36 months is necessary to address the surveillance question, and you do not agree, we will use the Medical Devices Dispute Resolution Panel to resolve the matter. You may obtain guidance regarding dispute resolution procedures from the Center for Devices and Radiological Health's (CDRH') Web site (http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHOmbudsman/default.htm.). The 36-month period refers to the surveillance period, not the length of time from the issuance of the order.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.