§822.25. What are my responsibilities after my postmarket surveillance plan has been approved?
21 C.F.R. § 822.25
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:
Postmarket surveillance is initiated in a timely manner;
The surveillance is conducted with due diligence;
The data identified in the plan is collected;
Any reports required as part of your approved plan are submitted to us in a timely manner; and
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.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 331, 352, 360i, 360l, 371, 374.
Source
Source: 67 FR 38887, June 6, 2002, unless otherwise noted.