FDA clarifies 21st Century Cures Act digital health regulations

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The FDA released two new guidances on Sept. 26 further outlining its regulatory process concerning the development and commercialization of new digital health technologies.

The first guidance concerns clinical decision support software. Besides distinguishing between types of software that will and will not be subject to FDA oversight, the document also notes that the FDA will now use a standardized framework to categorize these software products based on an assessment of the risk to patients posed by a software malfunction.

The second guidance offers clarity on several other digital health provisions within the 21st Century Cures Act, outlining the technologies that are no longer considered medical devices under the FDA's updated definition. For example, mobile apps and other tools that simply help users maintain a healthy lifestyle — that is, those digital tools that are valuable to consumers but pose a low risk — are excluded from the FDA's regulatory scope.

"Overall, these important guidance documents being issued today expand on our efforts to both encourage innovation in the ever-changing field of digital health and protect the public health," Amy Abernethy, MD, PhD, principal deputy commissioner of the FDA, said in a statement. "These documents are critical elements of FDA's comprehensive approach to digital health. We are committed to promoting beneficial innovation in this space while providing appropriate oversight where it's merited."

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