FDA General Wellness Product Policy Draft

This draft was replaced by a final guidance in August 2016. It is provided here for historical comparison only. FDA issued a draft “General Wellness: Policy for Low Risk Devices” guidance on January 20, 2015. This draft policy continues to redefine the borderline for FDA regulation/non-regulation of Health IT along with their MDDS and MMApps guidances. The decision algorithm is of particular interest, especially if one gets to question 2.

FDA General Wellness Policy Draft Jan 15

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Agile Methods for Medical Device and Health IT Software

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