FDA’s New Approach to Digital Health

Express Talk

April 16, 2019 | 1:30 p.m. – 1:45 p.m. CDT

FDA is proposing to change how it regulates software as a medical device (SaMD), which is medical software that meets the definition of device in the Federal Food, Drug, and Cosmetic Act. The hallmark of the change is a concept called Pre-Certification, in which FDA would permit marketing of certain software with minimal to no premarket review if software developers demonstrate to FDA that they have a culture of quality and organizational excellence. The proposed approach spans what FDA calls the total product lifecycle (TPLC) of a device, meaning there are premarket and postmarket features, including a premarket Excellence Appraisal and postmarket tracking of product performance and safety.

Session attendees will learn how FDA, through this proposed approach, would assure SaMD is safe and effective using a different regulatory model than what has been used for medical devices for the past 40+ years. Session attendees will also hear of the political challenges FDA faces in advancing this approach.


  • Aaron Josephson, Senior Director, ML Strategies