FDA Presentation: General Wellness Guidance: Policy for Low Risk Devices, 9/16
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In this September 2016 presentation, the CDRH branch of the FDA provides additional clarity regarding which medical devices for general wellness are considered low risk, and therefore will not be held to FDA regulations, such as 21 CFR 807 (Registration, listing and premarket notification), 21 CFR 801 and 809 (Labeling), 21 CFR 820 (GMP), and 21 CFR 803 (medical device reporting).
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