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US FDA Lawyer Blog. Wednesday, January 21, 2015. FDA Releases Draft Guidances on Wellness Medical Devices and Accessories. The FDA issued two draft guidances on January 20 outlining its approach to regulating low-risk devices intended to promote general wellness as well as medical device accessories. In the draft guidance General Wellness: Policy for Low Risk Devices. The FDA states that it will not regulate. Treat or diagnose obesity;. Treat eating disorders, such as anorexia;. Help treat anxiety;.
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