David Rosen Comments on the FDA’s Software Pre-Cert Pilot Program

14 October 2022 MobiHealth News News

Foley & Lardner LLP Partner David Rosen is featured in the Mobi Health News article, “Q&A: The FDA’s challenge in regulating evolving digital health tools,” discussing the U.S. Food and Drug Administration’s (FDA) recently concluded Software Precertification Pilot Program and how digital health companies need to approach the regulatory process.

Rosen said, “The whole idea behind the Pre-Cert program was to look at different regulatory approaches to try to assist companies in developing software for use as a medical device. And it was predicated on companies making sure that they have a robust quality organization and organizational excellence, and that they do some real-world monitoring of the software as it's being used.”

He noted while the pilot Pre-Cert program was helpful for both companies and the FDA, the FDA decided that the current regulatory paradigm isn’t the best fit to deal with software as a medical device. Rosen emphasized that digital health and health tech companies should closely watch what the FDA is going to do in the future.

“It needs to be a cooperative approach between the industry and FDA to move this whole situation forward to help bring new products into the marketplace,” he added.