FDA releases long-awaited clinical decision support guidance, clarifies oversight of mobile apps

Remigio Civitarese
Dicembre 8, 2017

FDA Commissioner Scott Gottlieb, MD, released three policy guidelines December 7 outlining the agency's approach to digital health oversight. "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".

Additionally, it said, "The FDA would like to bring to the attention of institutions dealing in medical devices that donation of medical devices are regulated by the FDA under the Public Health Act, 2012, Act 851". They include 2 draft proposals and 1 final guidance. The draft guidance outlines digital health technologies - such as mobile health and lifestyle apps - that FDA officials have determined fall outside of the agency's purview.

FDA published "Technical Considerations for Additive Manufactured Medical Devices", a guidance document for industry and the FDA staff, on Dec.5 and said it is the world's first agency to provide a comprehensive technical framework to advise manufacturers creating medical products on 3D printers. According to the guidance, analytics technology meant to support clinical diagnoses that provides room for a physician to independently review the basis of the software's recommendations would not be regulated by the FDA. Low-risk patient decision support tools, like software reminds patients to take their medications, will likewise be exempt from oversight. These technologies "no longer qualify as medical devices that would be subject to the FDA's oversight", according to Dr. Gottlieb. 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 guidance addresses a variety of issues, from design, software, and materials (both starting materials and reuse of materials) to post-processing, device testing, biocompatibility, and labeling.

The draft also proposes to not enforce regulatory requirements for lower-risk decision support software meant to be used by patients or caregivers, including software that reminds a patient how or when to take a prescribed drug. In the proposed changes, the agency will recommend updating the categories by which it defines medical devices to clearly exempt such software. Drafted in October 2016, the final guidance expands on that draft and establishes common principles for regulators to use in evaluating the safety, effectiveness and performance of Software as a Medical Device (SaMD). Gottlieb wrote that the final guidance includes input from the FDA's worldwide counterparts to outline "globally recognized principles for analyzing and assessing SaMD, based on the overall risk of the product".

"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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