StacksVerified U.S. regulatory reference

21 CFR §822.25

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
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:
  1. (a)Postmarket surveillance is initiated in a timely manner;
  2. (b)The surveillance is conducted with due diligence;
  3. (c)The data identified in the plan is collected;
  4. (d)Any reports required as part of your approved plan are submitted to us in a timely manner; and
  5. (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.