The FDA laid out its latest thinking on digital health tools in a package of six guidances released last week, highlighting the continued need for innovation.
Part of the agency’s implementation of its Digital Health Innovation Plan, the documents include one revised draft, one final guidance and updates to four previously released final guidances.
“Our aim is to provide more clarity on our risk-based approach to digital health products, and, in particular, to provide more detail on those technologies and applications that would no longer be classified as a medical device,” said FDA’s Principal Deputy Commissioner Amy Abernethy.
The revised draft guidance advises on clinical decision support (CDS) software designed to help providers identify the best treatment plan for a patient’s disease or condition. The revision clarifies the agency’s oversight of such software products, based on public comments on a 2017 draft.
The agency’s final guidance explains changes to medical software policies as a result of a regulatory amendment that removed certain software functions from the definition of medical devices. Mobile apps that only encourage a healthy lifestyle, for example, are generally not under the eye of the FDA, as they pose a low risk.
The updates to the four already-released final guidances bring them in line with current regulations. They address medical device data systems, image storage devices and communications devices, device software functions and mobile medical apps, policies for low-risk devices, and the use of off-the-shelf software in devices.
Read the revised draft guidance here: www.fdanews.com/09-26-19-SupportSoftware.pdf.
Read the final guidance here: www.fdanews.com/09-26-19-ChangesSoftware.pdf.
Read the updated final guidances here: www.fdanews.com/09-26-19-Guidances.pdf. — James Miessler