October 30, 2019

Senators Warren, Murray, and Smith Raise Further Questions About the FDA's Oversight of Digital Health Devices

Lawmakers Request More Information About FDA Pilot Program's Ability to Ensure Device Safety

Text of the Letter (PDF) | Text of FDA Response (PDF)

Washington, DC - United States Senator Elizabeth Warren (D-Mass.), member of the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee, U.S. Senate HELP Committee Ranking Member Patty Murray (D-Wash.), and Senator Tina Smith (D-Minn.), member of the U.S. Senate HELP Committee, sent a letter to the U.S. Food and Drug Administration (FDA) requesting additional information from the agency regarding its Software Precertification (Pre-Cert) Pilot Program.

The FDA established the Pre-Cert Pilot Program in 2017 to test the feasibility of a "precertification" system for developers of software as a medical device (SaMD), such as mobile health apps, medical software, and health information technology.

In October 2018, Senators Warren, Murray, and Smith sent a letter to the FDA requesting information about the pilot program. The FDA provided a detailed response in June 2019, which the lawmakers released publicly today. After reviewing the FDA's response, the senators remain concerned with key components of the Pre-Cert Pilot Program, including whether the regulatory regime envisioned in the pilot can adequately ensure the public safety and whether the FDA has the authority to conduct the pilot under current law.

"Digital health devices can be innovative, transformative, and have the power to alter America's health landscape," wrote the senators. "However, it is essential that changes to the FDA's regulatory framework are done in compliance with the current statutory framework and do not compromise public safety. Based on the updated materials you have provided us...we continue to have concerns about the program."

The lawmakers' letter includes a series of follow-up questions requesting detailed information about the agency's progress in developing and testing the efficacy of the pilot program. They requested responses to questions on these concerns no later than November 20, 2019.