Senators voice concerns with FDA software precertification program

Sen. Elizabeth Warren (D-Mass.) and two Senate colleagues are calling into question the statutory basis of a Food and Drug Administration software precertification program aimed at fast-tracking digital health products to market.

Warren, along with Sens. Patty Murray (D-Wash.) and Tina Smith (D-Minn.), sent a letter to the FDA this week challenging the appropriateness of the De Novo Pathway as a statutory basis of the pilot program.


In 2017, the agency selected nine technology vendors to participate in a pilot to help assess how pre-certified companies could bring certain types of applications to market without FDA premarket review or after a more streamlined premarket review process.

However, Warren—a Democratic presidential candidate—and her colleagues are questioning the FDA’s overall approach to the program.

“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,” states the letter from the senators. “Based on the updated materials you have provided us on the Pre-Cert Pilot Program, we continue to have concerns about the program.”

According to the letter, the three lawmakers have multiple concerns, including:

• The FDA’s ability to ensure public safety under a “precertification” regime, particularly through its proposed “Excellence Appraisals.”

• The appropriateness of the De Novo pathway as a statutory basis for the pilot.

• The agency’s use of real-world performance data to assess the safety and efficacy of software as a medical device (SaMD) approved through the pilot.

According to the FDA, SaMD ranges from software that enables a smartphone to view images obtained from a magnetic resonance imaging medical device for diagnostic purposes to computer-aided detection software that performs image post-processing to help detect breast cancer.

However, the senators have concerns about the FDA’s requirements for post-market surveillance and real-world performance analytics. Pilot participants must share real-world performance analytics, usage data and software information on a quarterly basis. But, as the senators point out in their letter, the agency does not intend to collect the raw data upon which the analytics are based.

To address these and other concerns, the senators have requested detailed answers by November 20 from the agency to dozens of questions in their letter regarding the Pre-Cert Pilot Program. In addition, lawmakers want the FDA to release three documents to “provide additional insight into the Pre-Cert Pilot Program and the agency’s plans for regulating digital health technologies.”