FDA pilot program aims to streamline digital health approvals

The FDA is launching a pilot program that would precertify software developers who could then be able to market digital health products with no additional FDA review or faster review.

The FDA rolled out (PDF) its Digital Health Innovation Action Plan, which includes a precertification program aimed at speeding up the approval process for digital health software that poses a lower risk than traditional medical devices.

“Historically, healthcare has been slow to implement disruptive technology tools that have transformed other areas of commerce and daily life,” said FDA Commissioner Scott Gottlieb in a blog post Thursday.

“FDA’s traditional approach to medical devices is not well suited to these [digital health products]. We need to make sure our approach to innovative products with continual updates and upgrades is efficient and that it fosters, not impedes, innovation,” Gottlieb said.


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The agency is launching a pilot program to help it establish criteria for a precertification program for companies that make digital health products. The program will develop a “tailored approach” for digital health by looking first at the developer of the digital health technology or software, rather than at the product.

This “firm-based” scheme could lead to the precertification of digital health developers based on objective criteria. Once a company is precertified, the FDA said, they could market their lower-risk medtech offerings without additional FDA review, or with a less onerous premarket review.

The FDA is inviting nine companies to participate in the pilot. The agency aims to include both startups and large companies, as well as nontraditional developers and traditional devicemakers who also make low-risk software products.

The action plan focuses on changes the FDA can make in the coming year to ensure its policies and processes "match the needs" of digital health technology. The plan also includes hiring more staff for the Center for Devices and Radiological Health’s Digital Health Program and updating existing policies and issuing new guidance to “provide greater clarity” on the software provision of the 21st Century Cures Act.

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