§ 822.6. When will you notify me that I am required to conduct postmarket surveillance?
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/us/cfr/t21/s§ 822.6·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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.