ARTICLE SUMMARY:
In this week’s Pathways Picks: Many FDA device center reviewers fired earlier this month were called back to work; LDT rule in court; EU proposes electronic instructions for use for all professional-facing devices; cardiologists propose centralized European device review; industry groups call EU MDSAP membership; and more updates from the EU, Canada, the UK, and Brazil.
US Picks
CDRH staff called back, but more layoffs could be coming, LDT rule defense, and Makary awaits hearing:
Whiplash at CDRH. One week after more than 200 “probationary” employees from FDA’s device center received notices terminating their employment, some of them reportedly received calls this past weekend reinstating their positions. There are no official figures on how many people the agency laid off, what proportion have been called back, and who agreed to return. Reports suggest many of the 100-plus fired reviewers who conduct work funded by MDUFA V user fees have been offered their jobs back. “I’m happy to be back to work supporting the Agency’s mission,” Nathan Weidenhammer, PhD, a reviewer in FDA’s Office of Cardiovascular Devices, wrote in a February 25 LinkedIn post announcing his reinstatement. Sandi Supinda Watcharotone, PhD, another cardiovascular device reviewer, also announced her return in a same-day post. “I reluctantly accepted worrying what the future holds for federal workers,” she said. The rescissions came after AdvaMed sent a letter to HHS Secretary Robert F. Kennedy Jr. warning that the cuts, which disproportionately impacted CDRH over the drug and biologic centers, would hurt patient care and undermine gains made by the device user fee agreement.
