Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Pharma & MedTech Business Intelligence’s The Gray Sheet, in “Pre-Cert Program Will Start Off Slow with De Novo Framing, but Big Questions Remain,” by Ferdous Al-Faruque. (Read the full version – subscription required.)
Following is an excerpt:
Several experts suggest FDA is toeing the line in keeping the first stage of its pre-certification program for software-as-a-medical-device products legally permissible, but it may be limited in scope for the time being. Meanwhile, one attorney says the agency is sending mixed messages about whether the current program will sit comfortably within FDA’s current authorities. …
“The pre-certification program would be limited to that 1% of medical devices that are unprecedented. That is a very small slice, and will therefore be of limited interest to the software industry,” attorney Bradley Thompson says. …
Another question might be whether reliance on the de novo program will restrict the impact of the pre-cert approach on FDA’s oversight of SaMD products.
Experts point out that the de novo pathway is only open to low-to-moderate-risk devices that do not have a predicate product or are otherwise considered unprecedented.
“FDA has been selling this pre-cert program as the best thing since sliced bread for essentially all software as a medical device,” said Bradley Merrill Thompson, an attorney at Epstein Becker & Green who works with digital health, device firms and combination product-makers. “Now they’re saying that, at least initially, it will be restricted to unprecedented software.”
Thompson says the approach will limit the number of SaMD products that will be able to leverage the pre-cert program, pointing to the handful of de novos that get through the agency each year compared to the thousands of 510(k)s that FDA clears annually.
“This means that the pre-certification program would be limited to that 1% of medical devices that are unprecedented,” said Thompson. “That is a very small slice, and will therefore be of limited interest to the software industry.
“If we ask ourselves why FDA would restrict to these products, the answer seems reasonably clear: to solve the problem of FDA’s lack of legal authority,” he added. …
Thompson has been critical of FDA’s pre-certification program, and has argued that the approach laid out by the agency in its previous working model documents goes beyond its current legal authority.
The attorney says he finds the contents of the new pre-cert test plan “satisfactory,” noting for 2019, the document suggests all of the existing statutes and regulations will be followed. “In the future, after they’ve developed the final approach, they would seek statutory authority. I support that,” Thompson added.
But he remains concerned that the other three documents issued at the same time as the test plan – the regulatory framework, the updated working model and an extended statement by FDA Commissioner Scott Gottlieb – are not all consistent on the details.
Thompson says that FDA seems to want to leverage special controls created in a de novo process to “undo the 510(k) process going forward for these products. That’s not legally kosher. Special controls add; they do not subtract requirements. And, in particular, the requirements under 510(k) are a general control. If FDA wants to exempt or otherwise modify those requirements, there is a defined process for the agency to use.”
He also thinks FDA might be going outside its authority with regard to pre-market inspections for de novo requests.