US senators Elizabeth Warren (D-Mass.), Patty Murray (D-Wash.) and Tina Smith (D-Minn.) have penned another letter to the FDA expressing concern over the agency’s PreCert program.
In it, the senators acknowledge the opportunities for digital health, but also question the proposed regulation's ability to ensure safety of the products. The 10-page letter asks 18 pointed questions about the program...
The FDA’s Pre-Cert program has fallen under new scrutiny as the agency received an open letter today from three senators: Elizabeth Warren (D-Mass.), Patty Murray (D-Wash.), and Tina Smith (D-Minn.).
The 12-page letter contains no less than 50 questions for the agency about the program, ranging from how it will derive its statutory authority to how it will pay for the program absent traditional...
