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§ 822.25 - What are my responsibilities after my postmarket surveillance plan has been approved?

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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.

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§ 822.24 - What are my responsibilities once I am notified that I am required to conduct postmarket surveillance?
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§ 822.26 - If my company changes ownership, what must I do?