ARTICLE SUMMARY:
In this week’s Pathways Picks: FDA’s device center is hit hard by the Trump administration’s mass layoffs of government workers this weekend; AdvaMed implores newly confirmed HHS Secretary RFK Jr. to reverse the cuts; CDRH reengages on standards; Medicare inpatient proposal is under White House review; China reports on 2024 device approval trends; ANVISA reconsiders procedures for borderline products; a new EU IVDR notified body; and more.
US Picks
Trump firings hit CDRH, and RFK Jr. takes the helm at HHS:
CDRH staff slashed. Reviewers and scientists across FDA’s device center were fired February 15, raising questions throughout industry about the current capacity to perform premarket reviews, meet user fee performance commitments, and carry out other activities. Among the terminated staff was Ross “Rusty” Segan, who joined CDRH last fall to run its Office of Product Evaluation and Quality (OPEQ), which houses all of the center’s premarket review staff, as well as surveillance and compliance officers. The actions came as part of the Trump administration’s mass terminations of “probationary” employees carried out at federal agencies over the President’s Day weekend.
More than 200 CDRH employees received termination notices, according to multiple sources speaking on background, accounting for about 10% of the center’s workforce. Many of the impacted individuals were hired in the past year or two, but there are also more experienced scientists who originally joined FDA under a fellowship and entered a new probationary period after officially transitioning to a civil service position. Industry sources with close ties to the agency suggested departments focused on medical imaging, diagnostics, artificial intelligence, cybersecurity, and diabetes devices were among the most impacted. For more details and updates on the FDA layoffs, see in Market Pathways: “Trump Firings Impact Device Reviews As Industry Underscores Patient Risk and Fee Commitments.”
