Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Inside Health Policy, in “Lawyers: FDA Proposed De Novo Rule Might Discourage Developers,” by David Roza. (Read the full version – subscription required.)
Following is an excerpt:
Four device industry lawyers said the de novo rule proposed by FDA Dec. 4 could discourage product developers from entering the de novo pathway by making the route resemble the beefier premarket approval (PMA) process, which is typically reserved for higher risk devices. The de novo pathway is intended for lower risk medical devices for which there is no predicate device to be compared.
The lawyers specifically criticize the rule’s allowance of premarket manufacturing inspections; new grounds for denying de novo clearance; process for requesting device samples for de novo submissions; and lack of detail on how FDA would notify developers of a de novo denial, why it would issue a denial, and how developers might appeal a denial. …
The first thing the lawyers criticize is FDA’s decision to use a proposed rule instead of guidance to clarify the de novo process. Brad Thompson, a member of the firm Epstein Becker Green, said FDA had already provided plenty of clarity on the de novo process through guidance.
“Honestly, my reaction is confusion,” Thompson said. “Regulations don’t typically offer clarity, they offer permanence. So, I’m simply not sure I understand what it is FDA was trying to do, and whether they were trying to help themselves in the enforcement context or help industry. The advantage to industry is simply not clear.”