FDA Draws Line between Regulated and Unregulated Digital Health Products


Posted December 14, 2017

The Food and Drug Administration (FDA) has published three guidance documents—two drafts and one final—intended to clarify the agency’s role in regulating digital health products, including areas where the agency sees no need for its involvement. That approach, according to the FDA, will allow it to focus its resources on the highest risk products and will foster innovation.

“We recognize that our regulations play a crucial role in the development of tools that can help people be more informed about their health. Therefore, our approach to regulating these novel, swiftly evolving products must foster, not inhibit, innovation, while protecting public health,” the FDA wrote in an email to stakeholders.

Changes to Existing Medical Software Policies

The first draft guidance document, Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act, details the types of software the FDA no longer considers medical devices based on the provisions laid out in the 21st Century Cures Act.

“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,” said FDA Commissioner Scott Gottlieb in a statement. “Such technologies tend to pose a low risk to patients but can provide great value to consumers and the healthcare system.”

The draft also proposes changes to previously published guidance documents, including General Wellness: Policy for Low Risk Devices; Mobile Medical Applications; Off-The-Shelf Software Use in Medical Devices; and Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices, to be more consistent with the Cures Act and “help manufacturers understand what products meet the definition of ‘device’ under the new law.”

Clinical and Patient Decision Support Software

The second draft, Clinical and Patient Decision Support Software, clarifies the types of clinical decision support tools that will continue to be regulated by the FDA. Software programs “intended to process or analyze medical images, signals from in vitro diagnostic devices, or patterns acquired from a processor like an electrocardiogram … remain medical devices under the Cures Act,” according to Gottlieb.

The FDA has proposed not regulating clinical decision support software that allows a healthcare provider to independently review the basis for a recommendation about the prevention, diagnosis, or treatment of a disease or condition, and lower-risk decision software intended to be used by patients or caregivers, known as patient decision support software.

“We believe our proposals for regulating digital health products not only fulfill the provisions of the 21st Century Cures Act, but also strike the right balance between ensuring patient safety and promoting innovation,” the FDA said.

Some stakeholders, such as Bradley Merrill Thompson, general counsel for the industry group Clinical Decision Support Coalition, were disappointed that the agency didn’t draw a clearer line between regulated and unregulated clinical decision support software.

“What I think many of us in [the] industry were hoping for was an effort by FDA to distinguish high from low risk as a basis for regulation. We didn’t get that. Worse, it appears, based on the guidance, that FDA is not interested in drawing that line,” Thompson, who was providing his personal views, told MedCityNews.

Software as a Medical Device

The third guidance document, Software as a Medical Device (SaMD): Clinical Evaluation, establishes common principles for regulators to use in evaluating the safety, effectiveness, and performance of this type of software. The final version of this guidance, which was initially published in October 2016, is the result of the agency’s international harmonization efforts.

“This final guidance provides globally recognized principles for analyzing and assessing SaMD based on the overall risk of the product,” Gottlieb said. “Through this comprehensive approach, we can deliver on our commitment of promoting beneficial innovation in this space while providing the proper oversight where it’s merited.”