ARTICLE SUMMARY:
The CDRH impact of HHS’ Large-Scale HHS Layoffs. Excerpted from Pathways’ Picks April 9: CDRH Fallout, Dr. Oz Confirmed, China and South Korea Innovation Proposals, and More.
Upwards of 250 staffers at FDA’s device center lost their jobs as part of the large-scale HHS reduction-in-force (RIF) action conducted April 1, sources with knowledge or connection to internal CDRH operations told Market Pathways. That represents about 11% of the device center workforce employed at the start of 2025 and a larger proportion the numbers that remained in the wake of prior reductions and incentivized resignations since President Trump took office in January. The cuts eliminated several entire offices and divisions within the center, but it doesn’t appear any device reviewers were targeted. The most significant impacts were on CDRH officials that oversaw financial and performance metrics (including for the MDUFA V user fee program), implemented policy, and managed communications, including 510(k) summaries and safety notices. For a more detailed account of the current situation at CDRH, impacts on the user fee program, and potential reorganizations, see in Market Pathways: “What’s Happening at CDRH? A Look at Post-RIF Device Center Realities.”