Senators Voice Concerns About FDA’s Software Precertification Program

Three Democratic senators raised new concerns about the FDA’s digital health pre-certification program and pressed the agency for more details.

The Oct. 30 letter from Sens. Elizabeth Warren (D-Mass.), Patty Murray (D-Wash.) and Tina Smith (D-Minn.) came one year after another letter to the FDA outlining similar concerns.

In the Oct. 10, 2018 letter, the three senators included more than 20 questions on the program, including the FDA’s legal framework, the qualification process, monitoring and postmarket surveillance, and the agency’s ability to oversee digital health products.