ARTICLE SUMMARY:
FDA lends a hand to companies pursuing De Novo authorization. Excerpted from Pathways’ Picks October 21: CDRH Hiring, EU Reform Timeline, AI Policy Plans, and More.
FDA plans to offer extra assistance for companies that pursue De Novo authorization but are beaten out by a competing company developing a similar product. Such second-place finishers historically must regroup, start over, and consider submitting a 510(k). In MDUFA VI user fee negotiations earlier this year, FDA and industry agreed that the agency will reach out to firms in this situation offering a "glide path" to a 510(k) submission, explained AdvaMed's Geeta Pamidimukkala, VP of Technology and Regulatory Affairs, during an October 20 panel discussion at The MedTech Conference.
The provision was not mentioned in FDA's draft commitment letter issued over the summer, but Pamidimukkala and FDA officials affirmed it will be part of the agreement that is up for reauthorization next year. "You'll get a phone call and they will work with you to figure out how to make the next steps for you as smooth as possible," she said. Impacted companies will also qualify for a fee waiver or adjustment.