Guidances galore: FDA finalizes multiple digital health guidance documents

On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released a series of guidance documents addressing the agency's current views on software regulation following the changes implemented in the 21st Century Cures Act (Cures Act) enacted in December 2016.

Specifically, FDA released a final guidance document entitled "Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act" (changes guidance) along with updated guidance on mobile medical applications (MMA), medical device data systems (MDDS), general wellness products, and Off-the-shelf Software. The final guidances confirm and clarify the exclusions of certain types of software functions from the definition of a medical device as mandated by the Cures Act.

While this set of final digital health guidances primarily confirm existing changes and do not represent major policy shifts, the agency also released a draft guidance entitled "Clinical Decision Support Software" (CDS guidance), which substantially revises the draft guidance that was released in 2017 and is the subject of a companion client alert. Together, these guidances build on FDA's efforts to bring the regulatory framework for software and digital health products into line with the Cures Act.

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