FDA releases regulatory framework for digital health: 4 things to know

The FDA has drafted a new regulatory framework outlining how it wants to review digital health products, based on a pilot program the agency rolled out in 2017.

Four things to know:

1. The FDA's pilot, dubbed the Digital Health Software Pre-certification Program, aims to create a streamlined approval process for digital health products. Under the program, the FDA reviews developers — rather than individual products — with the underlying premise that digital health products should be evaluated differently than traditional medical devices, since software is frequently updated.

2. Since the pre-cert program debuted, the FDA's digital health team has been working with patients, providers and the nine companies it selected for the initial pilot — which included tech giants like Apple and Fitbit — to create a new regulatory framework.

"Digital tools are rapidly evolving, and to keep pace with this promising innovation, the FDA must modernize its approach to regulation," FDA Commissioner Scott Gottlieb, MD, said in a statement announcing the release of the draft framework Jan. 7.

3. The regulatory framework seeks to test new approaches for the review of digital health products based on the FDA's findings from the pilot program. The FDA released an outline, test plan and working model of the framework Jan. 7, which Dr. Gottlieb said will "launch [the FDA] into the next phase of the agency's vision of pre-cert."

"Together, the plans we're launching today demonstrate our ongoing commitment to building a pre-cert program that recognizes the unique and iterative characteristics of digital health products, as well as their significant potential to improve the lives of patients," he added.

4. Dr. Gottlieb said the FDA will solicit public input on the pre-cert program as the agency continues to implement elements of the program in the coming months.

To download the FDA's outline of the regulatory framework, click here.

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