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.