October 10, 2018

Warren, Murray, Smith Press FDA on Oversight of Digital Health Devices

Senators Raise Questions About Agency's Pilot Program to Pre-Certify Software Developers Rather Than Products

Text of the Letter (PDF)

Washington, DC - United States Senator Elizabeth Warren (D-Mass.), along with Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member Patty Murray (D-Wash.) and Senator Tina Smith (D-Minn.), today sent a letter to the U.S. Food and Drug Administration (FDA) to express concern about the agency's proposed regulation of digital health devices and to request information on how the FDA plans to use its precertification pilot program - which will focus on reviewing and certifying the developer of potential digital health products rather than the products themselves - to ensure the safety and efficacy of health software products.

Digital health devices - such as mobile health apps, medical software, and health information technology - are innovative, transformative products that have the power to fundamentally alter America's health landscape.  To help streamline FDA's review of certain low-risk digital health products, such as electronic health records and fitness tracking software, Congress in 2016 exempted these types of products from device regulation.  However, the FDA has further concluded that its existing review process is not well-suited to evaluate other types of higher-risk digital health devices.  To accommodate these differences and further streamline its process, the FDA released a Digital Health Innovation Action Plan, which includes a "software precertification pilot program."

While the senators recognized the FDA for its efforts to modernize its regulatory approach to digital health devices, they also raised concerns about how the agency will ensure it is exercising sufficient oversight over these software products.

"We support FDA's efforts to update the medical device review regime to better accommodate digital health devices and believe that it is an important step in ensuring that America remains an innovative, cutting-edge producer of medical devices," the senators wrote in their letter to FDA Commissioner Scott Gottlieb. "However, it is essential that changes to FDA's regulatory framework are done in compliance with the current statutory framework and do not compromise public safety."

The senators' letter outlined their concerns in detail and asked the FDA to answer a series of questions regarding the precertification program. Their questions involved the statutory framework and qualification for precertification, effective monitoring and post-market surveillance of digital health products, and the FDA's capacity to oversee these 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 senators continued.

The senators requested answers to their questions by no later than November 9, 2018.