Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MedTech Dive, in “FDA Targets De Novo Path to Shepherd Medical Software Through Pre-Cert,” by David Lim.
Following is an excerpt:
The FDA has been working for several years to revamp how it reviews software as a medical device as more companies move into the space with wearables and other hybrid products. Nine companies including Apple, Fitbit and Johnson & Johnson are part of the pilot.
Commissioner Scott Gottlieb said in a statement the agency still plans to test its pilot program this year.
But one industry lawyer questioned if FDA’s most recent iteration will severely limit the potential for the Pre-Cert program by depending on the De Novo pathway, which has historically seen little use compared to its 510(k) program.
“FDA has been selling this precert program as the best thing since sliced bread for essentially all software as a medical device,” said Brad Thompson, an attorney at Epstein Becker Green. “Now they’re saying that at least initially it will be restricted to unprecedented software. That is a very small slice, and will therefore be of limited interest to the software industry.” …
FDA laid out in a new document how it plans to utilize the De Novo pathway to conduct the pilot program under current authorities. A company would first be evaluated during a so-called excellence appraisal based on the principles outlined in the working model before submitting a Pre-Cert De Novo request. …
Thompson told MedTech Dive in an email that FDA’s plan to adhere to existing statutes and regulations before seeking statutory authority once a final approach for the Pre-Cert program is developed appears to assuage his concerns about regulatory overreach.
But the lawyer argued it is not clear FDA will take that approach, noting the agency’s four documents outlining its vision for the program “read very differently, and reconciling them is tough.” He also questioned if relying on the De Novo pathway will fulfill the initial vision for the Pre-Cert program given the low utilization of the pathway compared to the 510(k) program. …
FDA plans to hold a webinar Feb. 7 to answer developer questions about the Pre-Cert Pilot Program. The agency is also monitoring the continuous docket for public comments on the Pre-Cert Program approximately every two weeks, but comments on the new working model appear to be due March 8.
“In general, the working model seems very much still simply a concept paper rather than a true roadmap that provides the needed details to assess this program. I understand that they basically want to spend this year testing the program and developing some of those details. 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 told MedTech Dive.