Alerts
August 4, 2016
At long last, the Food and Drug Administration issued its Nonbinding Recommendations and Guidance regarding “General Wellness: Policy for Low Risk Devices,” announcing it will not regulate “low-risk general wellness products.” Low risk products, in turn, are defined as products that meet the following two factors: (1) are intended for only general wellness use, as defined in this guidance, and (2) present a low risk to the safety of users and other persons.

Although questions remain, particularly as to the scope and parameters of what constitutes a low risk device, the Recommendations are a welcomed addition to the dialogue and offer a reasonable, first step of balancing the safety concerns for individuals with the importance of encouraging technological innovation in the exciting and emerging field of Health Tech. 

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