FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Senators Question Digital Health Pre-Cert Program

Oct. 24, 2018

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

Sens. Elizabeth Warren (D-Mass.), Patty Murray (D-Wash.) and Tina Smith (D-Minn.) included more than 20 questions on the agency’s proposed framework for 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.

“The agency should be focused on ensuring it has the tools and capacity to guarantee that software products that perform medical device functions are safe and effective and to hold companies that skirt the rules accountable,” the letter states. “Instead, the Pre-Cert Pilot focuses heavily on the potential of standards for design, validation, and maintenance of software and the ability to capture post-market data to reduce premarket review time or eliminate the need for premarket review altogether.”

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