FDA seeks software developer test cases for precertification program

Agency is looking for volunteers planning to submit a De Novo Request or 510(k) submission to evaluate Pre-Cert working model.

The Food and Drug Administration is looking for volunteers planning to submit a De Novo Request or 510(k) submission to evaluate a working model for a new software precertification program.

The Pre-Cert program for software developers is aimed at fast-tracking digital health products to market. The regulatory agency released Pre-Cert 1.0—the first version of the program—and intends to further refine the proposed framework with help from industry.

“The FDA is seeking test cases from software organizations planning to submit a De Novo Request or 510(k) submission for software as a medical device (SaMD) in 2019 or shortly thereafter to meet the goals of the Test Plan,” states an agency announcement. “To ensure that the entire Pre-Cert framework is appropriately evaluated, the FDA intends to prioritize selection of premarket submissions (510(k) submissions or De Novo Requests) that will enable evaluation and testing of all four components outlined in version 1.0 of the Working Model.”

Specifically, the agency hopes to recruit volunteer cases to represent a broad spectrum of software developers, including small and large firms as well as vendors that develop a range of products for both low- and high-risk Software as a Medical Device (SaMD).

According to the FDA, SaMD ranges from software that enables a smartphone to view images obtained from a magnetic resonance imaging (MRI) medical device for diagnostic purposes to Computer-Aided Detection (CAD) software that performs image post-processing to help detect breast cancer.

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.

Also See: FDA picks 9 vendors for digital health software precertification pilot

While the FDA’s announcement last week states that it is seeking test cases from software firms to “inform the development of the Pre-Cert program as the FDA seeks to validate the Software Pre-Cert Pilot program,” the agency makes clear that it “does not intend to provide precertification for companies during the testing in 2019.”

Bradley Merrill Thompson, an attorney at Washington-based law firm Epstein Becker Green who counsels medical device companies on regulatory issues, says he sees in the agency’s latest announcement about test cases—and “opening this up to other companies”—a departure from prior FDA statements regarding the Pre-Cert program and pilot.

“That was not the plan as recently as January,” contends Thompson. “They thought they had enough to do with just the nine pilot participants. It makes me wonder if some of the nine have needed to drop out for some reason. Just speculating, but obviously it’s possible that when the companies signed up to be in the pilot in August 2017, they may not have known what their submission strategy would be for 2019. In the interim, products that they were working on might have fizzled. Or there might be other reasons that they would choose to leave the program.”

According to Thompson, another departure from prior FDA statements appears to be the agency’s intention to solicit those software developers who plan to submit 510(k)s. He points out that earlier this year, the agency released a document with plans to implement the Pre-Cert Pilot Program under the De Novo pathway initially.

“Again, as recently as January, FDA said that its plan was to limit this to those submitting De Novos, and that they would proceed along the two different regulatory paths simultaneously,” observes Thompson. “This is important because they do not have legal authority for this program from Congress. So, if they are now going to open it up to companies pursuing 510(k)s, I assume—but don't know—that they’re planning to do a parallel 510(k) review process along with the precertification program.”

He concludes that “given the extraordinarily slow pace of and little progress in developing the program over the last couple of years—and the fact that they will need legislative authority—the future of the program is quite uncertain.”

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