FDA clarifies differences between general wellness and regulated medical devices

On January 20, 2015, the FDA issued draft guidance clarifying key distinctions between general wellness devices and those technologies that are regulated by the agency as medical devices. The guidance, entitled “General Wellness: Policy for Low Risk Devices,” provides important information for innovators working in the space. For a helpful summary of the guidance, visit MobiHealthNews. The complete guidance document is available on the FDA website.

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