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’s De Novo Pathway Is About to Get a Makeover,” by Meg Bryant.
Following is an excerpt:
Changes are coming to FDA’s medical device De Novo classification process and industry said clarity on the process cannot come soon enough.
Included on the Office of Management and Budget’s Fall 2018 Unified Agenda are plans for a proposed rule establishing procedures and criteria for bringing novel Class I and Class II devices to market via the pathway. The goal is to bring more transparency and predictability for manufacturers, according to the docket. …
“Strategically, the De Novo process has become increasingly important to industry,” said Bradley Merrill Thompson, an attorney with Epstein Becker & Green, noting the increasing array of digital and other innovative devices that don’t fit existing classifications. “In the absence of reclassification, these products would be stuck in Class III and subject to the PMA process. For many of them, they are very low risk and the PMA process would be wholly inappropriate.” …
It’s clear that FDA and industry want to pursue more De Novos for novel devices, and that the process should be far less burdensome than a PMA. Still, the issue of first filer remains barrier, Thompson believes.
“The De Novo process requires one company to decide to invest substantial time and money pursuing the de novo classification, only to have that reclassification benefit all of its competitors,” Thompson said via email. “In other words, the first of the kind product has to blaze the trail for all those who want to follow, and those who follow can follow fast.”
