FDA Pre-Cert Program

David Rosen, a partner and public policy lawyer at Foley & Lardner, discusses the agency's recently wrapped Software Precertification Pilot Program and what it means for the future of digital health regulation.

FDA Comissioner Dr. Scott Gottlieb announced a new Digital Health Innovation Action Plan, Pre-Cert Test Plan for 2019 and a Working Model. 

The results to our poll about the FDA program prompt questions about the program's fairness to companies big and small.

In the last year the FDA has taken steps to evolve its process for regulating software as a medical device, personal genomics and clinical decision support technology.

Interest in digital health is now sprouting up all over DC, from the president’s announcement of a new AI task force to FDA Commissioner’s shout out to digital health in his budget request.

The FDA continues to move at a fast pace to develop and, soon, implement its pre-certification program for medical software development.

At AcademyHealth’s 2018 Health Datapalooza on Thursday, the US Food and Drug Administration offered a vote of confidence for artificial intelligence in healthcare, promising more refined strategies for regulation, touting its tech incubator for AI innovation, and announcing a new machine learning partnership with Harvard.

This morning, the FDA published its 17-page first draft of a working model for its pre-certification program for software as a medical device (SaMD).

In the last quarter the FDA gave the nod to 10 digital health devices.

Last September, Tidepool — a diabetes data management platform — was among the nine companies chosen to participate in the FDA’s experimental pre-certification program pilot.