Top Democrats question FDA Pre-Cert program safety, statutory authority

Dive Brief:

Top Democrats on the Senate's health committee on Wednesday asked FDA Commissioner Scott Gottlieb and CDRH Director Jeff Shuren for reassurances the agency will not sacrifice patient safety or overstep its statutory authority when implementing its software precertification pilot program.
The Pre-Cert program, which seeks to enable the agency to pre-clear qualified companies to update software without agency review to encourage innovation, is slated to launch a pilot in 2019 with nine companies including Apple, Fitbit and Johnson & Johnson.
While the senators commend the "ambitious set of goals" aimed at modernizing the agency's regulatory approach to digital health products, the letter raises multiple concerns including: FDA's consideration of opening the Pre-Cert program to companies without medical device experience; the use of third party organizations to conduct precertification assessments; and the potential negative implications for agency funding if user fees are not collected due to fewer applications being submitted.

Dive Insight:

The FDA appears to be confident within its authority. Bakul Patel, the agency's associate center director for digital health, said at The MedTech Conference late last month it plans to implement the pilot program through its current powers.

The concern that FDA may be overstepping its authority echoes comments submitted by the Clinical Decision Support Coalition, an industry group that has been active in responding to the FDA's development of the Pre-Cert program.

"The agency has waffled between wanting to simply wait to evaluate legal authority, and developing a program that could be supported by existing statutory authority," Brad Thompson, general counsel for the CDS Coalition, tells MedTech Dive.

"Senators raise legitimate questions about whether what FDA is planning could be done within the existing statutory authority," he wrote in an email.

The Democrats say that with the advent of Apple's ECG App, it is critical that consumers can have confidence in medical device software accuracy and safety in a new era of digital health.

"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. Instead, the Pre-Cert Pilot focuses heavily on the potential of standards for design, validation, and maintenance of software and the ability to capture post-market data to reduce premarket review time or eliminate the need for premarket review all together," wrote HELP Committee Ranking Member Patty Murray, D-Wash., Sen. Elizabeth Warren, D-Mass., and Sen. Tina Smith, D-Minn.

The senators specifically ask Gottlieb and Shuren to point to which statutory and regulatory authorities FDA plans on use in conducting the Pre-Cert pilot. The senators also ask if FDA anticipates needing new statutory authority to pre-certify companies outside of a pilot.

FDA says it will respond to the letter directly to the senators, but a spokesperson tells MedTech Dive the agency remains committed to oversight that ensures safe and effective digital health products.

"The agency is working with various stakeholders to design the Pre-Cert pilot while we explore executing the pilot within the agency's existing statutory authority," spokesperson Stephanie Caccomo said in an email. "We have been transparent about our proposed working model for the program, including seeking public feedback, and our goal is to publish the next iteration in December. We will continue to solicit public feedback as we continue developing the Pre-Cert pilot throughout 2019."

Kristin Zielinski Duggan, a medical device attorney at Hogan Lovells, tells MedTech Dive the agency "has a lot of flexibility on what they can do to streamline reviews," adding that some of the underpinnings of the Pre-Cert program are not unprecedented.

"You can kind of envision that there might be some ways, and maybe it isn't everything that is outlined in the working documents for the Pre-Cert program, but certainly there are ways for the agency to streamline reviews, have third parties be involved," Zielinski Duggan said. "Some of those concepts already exist today, so if they use some combination of that, it might be possible."