21 CFR 822.25
§ 822.25 What are my responsibilities after my postmarket surveillance plan has been approved?
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 822.25, § 822.25 What are my responsibilities after my postmarket surveillance plan has been approved?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88948
- Permanent ID
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Full text
After we have approved your plan, you must conduct the postmarket surveillance of your device in accordance with your approved plan. This means that you must ensure that:
(a) Postmarket surveillance is initiated in a timely manner;
(b) The surveillance is conducted with due diligence;
(c) The data identified in the plan is collected;
(d) Any reports required as part of your approved plan are submitted to us in a timely manner; and
(e) Any information that we request prior to your submission of a report or in response to our review of a report is provided in a timely manner.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.