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FDA Releases Much-Anticipated Digital Health Precert Model


Commissioner Scott Gottlieb, MD, also said his agency will reveal how it plans to review medical devices with more than 1 function.

fda digital health,digital health software precert,fda software,hca news

Image has been resized and cropped. Courtesy of the FDA.

When the FDA announced its digital health precertification pilot last year, some of tech and healthcare’s leading businesses signed on to map out paths for the regulator to more swiftly approve software updates. Now, the agency is preparing to unveil a working model of such a program.

FDA Commissioner Scott Gottlieb, MD, announced today that he would soon release the framework, which will lay out his agency’s vision for the digital health software precertification program and request additional input. The gist of the initiative: Healthcare software developers may one day volunteer to enter a fast track to FDA approvals, requiring front-end scrutiny of the company’s practices. The working model outlines how that would review process might work, along with premarket review and postmarket surveillance, according to the FDA.

“Given the benefits from empowering consumers, we believe the FDA must encourage the development of tools that can help people be more informed about their health,” Gottlieb said. “Our approach to regulating these novel, swiftly evolving products must foster innovation and maintain our gold standard for safety and effectiveness.”

>> READ: How Might the FDA’s New Pilot Program Transform Digital Health?

Launched last fall, the precert pilot attracted the likes of Apple, Fitbit, Johnson & Johnson, and other cutting-edge companies. Many other participants, eager to scope out what the FDA had in mind and to contribute their ideas, applied but were not accepted to the pilot. But the release of the working model provides all healthcare stakeholders the chance to comment.

The push for precert is part of the FDA’s Digital Health Innovation Action Plan, a movement started in 2017 and designed to bring the regulator and its approach into the 21st century. Since then, Gottlieb and his team have time and again touted the need for smoother digital health approvals and emphasized the importance of tech’s burgeoning role in medicine.

Furthering those goals, Gottlieb also announced today that his agency will issue draft guidance regarding how it plans to review medical devices that have more than 1 function. The move is meant to “provide transparency and clarity” to the FDA’s handling of a device that has one agency-regulated function and another that is out of its control.

“An efficient approach allows the agency to focus on those functions that the FDA oversees, while allowing the industry to modernize digital tools in ways that can deliver additional benefits,” Gottlieb said.

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