Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in InsideHealthPolicy, in “Experts Disagree Over Whether FDA Has Authority for PreCert,” by David Roza. (Read the full version – subscription required.)
Following is an excerpt:
Device industry experts disagree over whether a suite of new documents related to FDA’s nascent medical software precertification program answers a key question posed by stakeholders: Does the agency have statutory authority to implement precert? …
Brad Thompson, a member of the firm Epstein Becker Green, said the documents contain mixed messages on FDA’s authority that “make my head hurt.” …
Thompson supports the approach laid out in the 2019 test plan, which “suggests all of the existing statutes and regulations will be followed,” the lawyer said. “In the future, after they’ve developed the final approach, they would seek statutory authority.”
However, the other documents seem to take a different approach, Thompson added. By grounding its authority in the de novo process, FDA is limiting itself to software that does not have a predicate device with which to be compared. The lawyer estimated that only about 1 percent of premarket requests granted in 2018 were de novo. Limiting precert to such a small slice of software might not pique industry’s interest in the program, he said. …
Still, Thompson argued that the reason why FDA is limiting precert to de novo products is because the agency is still trying to figure out its legal authority for precert. That uncertainty seems to weave itself into the working model, which “seems very much still simply a concept paper rather than a true roadmap that provides the needed details to assess this program,” he said.
“I understand that they basically want to spend this year testing the program and developing some of those details,” Thompson continued. “That’s fine. But it will certainly be hard to get enthusiastic about this program in the absence of meaningful answers to these questions.”
Thompson said FDA’s position made no sense at the time, “but I now see that FDA wants to say that it has legal authority to do this premarket inspection as a part of its excellence appraisal process for the software precertification program.”
“Despite that motive, it doesn’t change the lack of FDA’s legal authority to require premarket inspections as a part of the de novo review process,” he added.