- A trio of Democrats on the Senate's health committee Wednesday wrote to FDA expressing concern about whether the agency's Software Pre-Certification Pilot Program can ensure public safety through excellence appraisals, the appropriateness of using the De Novo pathway for the pilot's statutory basis, and the effectiveness of real-world data being collected for postmarket surveillance of software as a medical device.
- The letter comes over a year after Sens. Elizabeth Warren, D-Mass., Patty Murray, D-Wash., and Tina Smith, D-Minn., first raised concerns about the Pre-Cert Program in a letter in October 2018. In June, FDA responded to the first letter, saying its efforts to establish a pre-cert program for emerging digital technologies is critical for smart regulatory oversight of a rapidly changing field.
- But their latest letter shows the senators' fears are not yet allayed; the trio is now asking FDA 18 detailed questions about how the agency is operating the pilot program, ranging from why it says Key Performance Indicators collected as part of excellence appraisals are confidential and protected from the Freedom of Information Act, to why pilot participants are not required to share data with the National Evaluation System for health Technology.
FDA maintains it has the statutory authority to conduct the software Pre-Cert pilot but in its June response to the senators' first letter, it acknowledged it may need Congress' help to fully implement the program.
An agency spokesperson told MedTech Dive while the pilot is necessary to assess the viability of its proposed approach, if it proves effective, it "would require new legislation to implement."
"We look forward to working with interested members of Congress on updating the 40-year-old regulatory paradigm for 21st century technologies," FDA spokesperson Stephanie Caccomo said.
Brad Thompson, a medical device attorney at Epstein Becker Green, said the senators' new letter drills down further on how FDA plans to assure patient safety after FDA's June response did not appear to alleviate their concerns.
"Among the places that FDA seem to sidestep direct questions, in response to the Senators' questions about the justification for permitting companies with little to no medical device experience to participate in Pre-Cert, the agency used a bunch of flowery language to talk about simply how open-minded FDA is," Thompson told MedTech Dive in an email. "But that's not what the senators asked."
The new letter also focuses heavily on FDA's argument it has the authority to conduct a pilot program using the De Novo program. In its June response, FDA maintained it has the authority to conduct its pilot under the existing De Novo classification process, but lawmakers, attorneys and industry trade groups appear to be questioning the agency's justification.
Thompson pointed to the senators' question about whether FDA believes Congress intended for the De Novo pathway to be used to establish pilot programs "that fundamentally alter the FDA's existing method of device review and approval" as an industry concern as well.
In March, AdvaMed formally told FDA resolving the question of statutory authority is critical, saying the promise of a SaMD Pre-Cert Program "may not be fully realized without legislative authorization."
"On the whole, the Senators 10-page letter reveals their intense interest in the details. While I approach the issue from a different direction, namely as a person who represents industry, it's interesting to me how we have so many of the same concerns," Thompson said.
The senators asked FDA to respond to the new letter by Nov. 20.
"We will provide responses to them." FDA's Caccomo said.