FDA releases separate guidance on CDS and medical software

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The Food and Drug Administration has issued revised draft guidance on the categories of clinical decision support software subject to FDA oversight.

The agency has issued the guidance in response to requirements of the 21st Century Cures Act, and it’s also put forth final guidance on the kinds of software no longer considered medical devices under the law.

The draft clinical decision support (CDS) guidance, based on public comments received on the previous draft published in 2017, is meant to provide clarity on the scope of the FDA’s regulation of software intended for healthcare professionals and patients.

“In this draft guidance, we propose to focus our regulatory oversight on CDS functions that are intended to help healthcare professionals and patients inform their clinical management for serious or critical conditions and that are not intended for healthcare professionals to independently evaluate the basis of the software’s recommendations,” says Amy Abernethy, MD, FDA’s principal deputy commissioner and acting CIO.

“We believe our proposed approach for regulating CDS not only fulfills the provisions of the Cures Act, but also strikes the right balance between ensuring patient safety and promoting innovation by clarifying which products would be the focus of FDA’s oversight and which would not,” adds Abernethy.

In addition, the agency’s final guidance—which updates four previously issued FDA final guidances—lays out the FDA’s interpretation of the types of software that are no longer considered medical devices under the Cures Act’s amended definition of device.

Section 3060(a) of the Cures Act amended section 520 of the Federal Food, Drug and Cosmetic Act (FD&C Act) on Dec. 13, 2016, removing certain software functions from the definition of device in section 201(h) of the FD&C Act.

The final guidance provides “FDA's current thinking regarding the amended device definition and the resulting effect the amended definition has on FDA's guidances related to medical device software,” according to the document.

“We’re making clear that certain digital health technologies—such as mobile apps that are intended only for maintaining or encouraging a healthy lifestyle—generally fall outside the scope of the FDA’s regulation,” contends Abernethy. “Such technologies tend to pose a low risk to patients, but can provide great value to consumers and the healthcare system.”

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