The FDA’s Pre-Cert program has fallen under new scrutiny as the agency received an open letter today from three senators: Elizabeth Warren (D-Mass.), Patty Murray (D-Wash.), and Tina Smith (D-Minn.).

The 12-page letter contains no less than 50 questions for the agency about the program, ranging from how it will derive its statutory authority to how it will pay for the program absent traditional user fees. The senators have requested a reply by November 9, 2018.

“FDA has outlined an ambitious set of goals for establishing a precertification program for SaMDs,” the senators wrote. “We appreciate that FDA continues to gather stakeholder input on the design of this program; however, we have a number of concerns with the vision of the program laid out over the past year.”

What’s the impact?

Warren, Murray and Smith’s letter is broken into sections. The first deals with FDA’s statutory authority and asks how and when the agency intends to seek Congressional approval. It also calls into question the FDA’s intention to grant preliminary or phased approvals, which might be a reference to the current pilot program.

The second section pokes holes in the FDA’s notion that any company should be able to apply for precertification and the notion that “excellence” should be defined flexibly by the program. It also raises questions about the notion of a third party being involved in evaluations.

But it’s the third section, about monitoring and post-market surveillance, that the legislators’ comments become especially pointed. Warren and company pick up on FDA language that has suggested companies might have too much control over their evaluation under Pre-Cert.

“The June working model envisions that ‘maintaining Pre-Cert status would be automated,’ suggesting that this status does not expire or need to be renewed by FDA,” they wrote. “According to the working model, tracking and monitoring ‘adherence to the excellence principles’ that qualify an organization for precertification would be performed not by FDA on an ongoing basis, but by ‘organizational leadership.’ In other words, software companies could be allowed to use an entirely self-policing review system in order to maintain a status that affords them valuable access to a streamlined review process, even for high-risk software and even if they have no prior experience marketing medical devices. This approach raises serious concerns about how FDA would ensure compliance with the goals and requirements of the precertification program.”

A final section asks the FDA how the agency will organize around the program and how it will pay for it — including whether there will be fees for participating companies and what form those will take.

What’s the trend?

Since new FDA Commissioner Scott Gottlieb announced the FDA precertification program, the agency has been moving full speed ahead to re-invent its process for clearing digital health products. Pre-Cert will emphasize a focus on evaluating “standards of excellence” for the company or firm, rather than focusing on specific products. The idea is that trusted shops will be able to iterate technologies at their own pace.

While many support the program, critical voices have also begun to emerge. Bradley Merrill Thompson, a member of the firm at Epstein Becker Green who also helps lead the Clinical Decision Support Coalition, laid out some of his own concerns in a recent editorial for MobiHealthNews.

In a recent reader poll, 63.4 percent of MobiHealthNews readers supported the program, 7.1 percent opposed it and 28.6 felt there wasn’t enough information currently available about the program.

This is the first significant public pushback we’ve seen to the program. While some of the concerns echo those raised in Thompson’s piece, others go even further, suggesting that there’s a risk of the proverbial foxes running the henhouse when companies are put in charge of their own evaluation, and at times even seeming to suggest that the FDA might be abdicating its responsibilities to ensure the safety and efficacy of medical devices.