Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Health Data Management, in “FDA Seeks Software Developer Test Cases for Precertification Program,” by Greg Slabodkin.

Following is an excerpt:

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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