What are my responsibilities after my postmarket surveillance plan has been approved?
21 C.F.R. § 822.25
in effectEffective: 2024-07-01After 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.
Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-21.xmlFetched: 7/26/2026