ARTICLE SUMMARY:
In this week’s Pathways Picks: More scientists and reviewers are leaving FDA’s device center, and at least one prominent device lawyer says their departures have already caused tangible delays; CMS plans Parkinson’s and tremors device coverage meeting; US and Europe medtech groups align on message to zero out medtech tariffs; German insurers seek digital health reforms; and more from the US, Norway, and China.
US Picks
CDRH departures and delays, CMS Parkinson’s meeting planned:
Departing CDRH scientists, reviewers. The April 1 HHS layoffs didn’t include any reviewers, but there are growing signs that more reviewers and scientists who provide expert consults on reviews are leaving the device center in response to pressure and instability within FDA. A PhD AI expert who performs review consults and research out of CDRH’s Office of Science and Engineering Laboratories (OSEL) told Market Pathways that about 20% of people in their division within OSEL have recently resigned. In addition, more managers and reviewers from the Office of Product Evaluation and Quality are publicizing their departures. For instance, Malvina Eydelman, MD, a 30-plus year CDRH veteran and long-time head of the office that reviews ophthalmology and ear, nose, throat (ENT) devices left FDA in March and recently took a post as the CEO of the Collaborative Community of Ophthalmic Innovation. Another example is Michael Bailey, PhD, who worked at CDRH for more than 20 years, most recently as a team lead for OB/GYN device reviews, and retired April 19.
Device delays observed. Whether the recent staff reductions at FDA have yet to show any systematic impact in slowing down device reviews has remained an open question. Jonathan Kahan, a partner at Hogan Lovells and long-time device regulatory expert who appeared April 28 on the FDA Watch podcast, says his firm is starting to notice a tangible impact. Attorneys at Hogan Lovells, which represents about 1,200 device firms, are reporting more and more problems during the firm’s weekly meeting, Kahan suggested. “We are seeing delays in Pre-Submissions. We are seeing delays in [additional information] letters. We are seeing delays in De Novo reviews, PMA reviews, 510(k) reviews,” Kahan said on the podcast. “Right now, it is too early to tell in the long term. But in the short term, we are seeing delays and some confusion on the part of the different reviewers and supervisors within CDRH.” (For more on the impact of recent reductions at the device center, see in Market Pathways, “What’s Happening at CDRH? RIFs, Retirements, User Fees, and Unknowns.”)
