When will you notify me that I am required to conduct postmarket surveillance?

21 C.F.R. § 822.6
in effectEffective: 2024-07-01
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We will notify you as soon as we have determined that postmarket surveillance of your device is necessary, based on the identification of a surveillance question. This may occur during the review of a marketing application for your device, as your device goes to market, or after your device has been marketed for a period of time.

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