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FDA Announces 3 New Digital Health Policy Changes


“We recognize that our regulations play a crucial role in the efficient development of such technologies,” Commissioner Gottlieb wrote in a statement.

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FDA Commissioner Scott Gottlieb, MD, today announced 3 policy changes meant to encourage digital health innovation while modernizing the agency’s oversight of new tech.

“We recognize that our regulations play a crucial role in the efficient development of such technologies,” Gottlieb wrote in a statement. “We must always lean in the direction of enhancing access to more information—not restricting information flow—given the ability of reliable information to positively impact daily life.”

All 3, according to Gottlieb, are meant to bring the FDA’s regulatory policies in line with the 21st Century Cures Act and “provide more clarity on innovative changes to our risk-based approach to digital health products.” They include 2 draft proposals and 1 final guidance.

The first draft guidance addresses clinical decision support (CDS) tools, outlining what technologies would and would not fall under FDA oversight.

The FDA’s new guidance says that when physicians can independently review the basis of recommendations made by CDS software, that software no longer constitutes a covered medical device. A CDS tool that recommends a doctor order liver function tests before having a patient begin statin therapy, for example, would no longer be covered so long as the suggestions are consistent with clinical guidelines and drug labelling. Low-risk patient decision support tools, like software reminds patients to take their medications, will likewise be exempt from oversight.

If CDS technology provides recommendations based on “analytical functionalities,” like a diagnosis based on spinal fluid analysis, it will still qualify as a medical device. The agency will continue to regulate tools that analyze medical images, information from in vitro devices, and patterns acquired from a processor like an EKG.

The second draft guidance pertains to the FDA’s interpretation of what digital health software qualifies as a medical device. The agency clarifies that “mobile apps that are intended only for maintaining or encouraging a healthy lifestyle” fall outside of its oversight because they are low-risk with potential for great benefit. In the proposed changes, the agency will recommend updating the categories by which it defines medical devices to clearly exempt such software.

The final guidance establishes common regulatory principles for the effectiveness, safety, and performance of Software as a Medical Device (SaMD). The draft was issued in October and finalized following domestic and international comment. Gottlieb wrote that the final guidance includes input from the FDA’s international counterparts to outline “globally recognized principles for analyzing and assessing SaMD, based on the overall risk of the product.”

Prior to being appointed FDA Commissioner, Gottlieb wrote extensively about the need for the agency to streamline review and clarify its oversight of technology, moving to more of a risk-based approach. In today’s statement, he posed the 3 policy changes as steps in that direction, and championed the efforts the FDA has already made toward enacting the Digital Health Innovation Plan he announced over the summer.

“We must adapt and evolve our policies to make sure we continue to provide a gold standard for oversight, while enabling advancement of beneficial innovations and greater consumer access to technologies that can improve their health,” Gottlieb wrote.

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