Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MobiHealthNews, in “Roche, J&J regulatory leads Weigh In on Pre-Cert’s Progress, Challenges of Regulating Digital Health,” by Dave Muoio.
Following is an excerpt:
Since it was first announced, fans and critics of the FDA’s Pre-Cert program for medical software developers have mused on the benefits and burdens that might come with participation in the experimental program. …
Intersection of software, drugs, AI is fraught with unknowns
Beyond the question of precertification, yesterday’s panel also dipped into a handful of the other efforts US regulators have made to define medical software, its applications and its review processes.
Speaking on the ambiguity of regulatory guidelines and pathways for digital products associated with drugs, Bradley Merrill Thompson, a partner at Epstein Becker Green who specializes in FDA law, described a recent survey his group conducted among health product manufacturers. When polled on the clarity of drug and device requirements for digital health, 42% of respondents felt that device rules were understandable for devices while 19% felt similarly for drugs.
“What they’re telling us is they go into FDA, and they’ve hired people from a device regulatory expertise in order to put them on the team for a combination product … and they’ve typically followed the [Center for Devices and Radiological Health (CDRH)] guidance on devices, on how to do a clinical trial or whatever the issue might be,” Thompson said later on during the panel. “They go in and they meet with FDA’s [Center for Drug Evaluation and Research (CDER)] responds ‘well, that’s a CDRH guidance. It doesn’t apply to what we’re talking about.’ And when pressed why, CDER would typically respond ‘Well, when you get specific about use of a piece of software with a particular drug, that’s different than the generalized approach that CDRH takes that’s not specific to a drug.’
“And I get that. It makes sense … but the frustration comes with saying ‘Well, what are the rules?’ There simply aren’t written FDA CDER guidance documents on how to deal with the software issues when the software is used in tandem with a drug. And an equal frustration is sometimes we get a sense that the CDER folks are taking the opportunity to take a fresh look at it. They’re not even grounding it in the CDRH position … our perception is that it’s being ignored.”