North America

Trio of US senators continue to question FDA's PreCert efforts

Senators Elizabeth Warren, Patty Murry and Tina Smith continued to express concerns about the PreCert's 'Excellence Appraisals,' De Novo pathway and real-wrold performance markers.
By Laura Lovett
12:54 pm

Photo by Sean Rayford/Getty Images

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 and asks for a response by November 20, 2019. 

“Digital health devices can be innovative, transformative, and have the power to alter America's health landscape. We support the agency's efforts to update its medical device review regime to better accommodate digital health devices,” the letter said. “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.”


The basic goal of the PreCert program, which sets it apart from previous FDA regulatory ventures, is that it will focus not on particular products but on firms and developers.

In the letter, the senators broke down three areas of concern about this approach. The first was that the precertification’s proposed “Excellence Appraisal,” or the set of qualities including health and safety that organizations will be evaluated on. In particular, the senators asked questions about agency's past statements that said companies can have some flexibility when tracking performance. 

The senators also questioned the agency’s ability to monitor whether a company was keeping up the "Excellence Principals." The letter went on to state that “the agency did not, however, provide any additional details on the data or evidence it used to determine companies’ adherence to the Excellence Principles."

The second major focus was on whether or not the De Novo pathway is appropriate as a statutory basis for the pilot program. The senators wondered whether the pathway, which was created in 1997 was intended to be fundamentally altered in this way. 

Lastly the letter touches on post-market surveillance and real-world performance. The letter asks how the agency plans on monitoring companies in the future. 


This group of senators has been going back and forth with the FDA for over a year nowOriginally the trio wrote a letter expressing concerns to the agency in September 2018. The agency wrote a reply to those concerns in June of 2019. This latest letter is a response to the June correspondence. 

Since former FDA Commissioner Scott Gottlieb announced the PreCert program, the agency has been moving full speed ahead to re-invent its process for clearing digital health products. The PreCert program has the potential to substantially change the way that medical devices are regulated. 

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