Devices

CDRH on Hiring Spree After Losing 22% of Workforce

CDRH is accelerating hiring after losing about 22% of its workforce over the past year and a half, including up to 30% of its clinical reviewers and significant numbers of artificial intelligence and digital health specialists. CDRH drector Michelle Tarver disclosed the staffing losses 10/21 at AdvaMed's MedTech Conference in Boston, according to MedTech Dive.

The staffing disruption followed sweeping reductions across HHS early in the Trump administration, including plans to eliminate about 3,500 FDA positions. The cuts disrupted agency operations, with some dismissed employees subsequently reinstated and remaining staff facing increased workloads.

Tarver said CDRH has hired more than 65 employees, exceeding its fiscal 2026 hiring target of 63 under the Medical Device User Fee Amendments (MDUFA) commitments. “We have actually exceeded our hiring for fiscal year ’26 under the MDUFA commitment, which is a herculean effort considering all the changes that have happened,” she said.

FDA officials announced over the summer that the agency had received authorization to hire 2,200 employees, although the allocation among FDA centers was not disclosed. Tarver said CDRH is still awaiting final hiring orders.

Despite the recent recruitment gains, Tarver emphasized that the center needs additional personnel to carry out its regulatory responsibilities. “We are not done,” she said. “We’ve got to hire more because we recognize that our center regulates 250,000-plus devices.”

Strong Stakeholder Support for PDUFA 8

Pharmaceutical Research and Manufacturers of America (PhRMA) says it strongly supports the draft PDUFA 8 commitment letter. The PhRMA comment says PDUFA 8 will help ensure the long-term sustainability of FDA’s human drug review program and strengthen agency capabilities by: * enhancing the efficiency of the drug review process

Bipartisan Policy Center Comment on Generative AI Devices

The Bipartisan Policy Center (BPC) says it supports FDA’s goal of a risk-based, least-burdensome approach that gives patients timely access to safe and effective generative artificial intelligence (AI) device functions. Responding to an FDA discussion paper on the subject, BPC makes these key points: * several approaches in

Improve FDA Myelodysplastic Syndromes Guidance

Researchers from Johns Hopkins and the University of Miami say myelodysplastic syndromes (MDS) therapeutic development is challenged by the syndromes’ biological diversity and regulatory risk. Writing in Blood Advances, the researchers say MDS is “ideal for FDA to implement flexible, biology-informed regulatory pathways. Establishing such frameworks in MDS could

Court Rejects FDA HCT/P Designation

A Georgia federal court has determined that FDA misread its own regulations in determining that a MiMedx wound care powder product was not a human cell, tissue, or cellular- or tissue-based product (HCT/P) because it was not minimally manipulated. Attorneys Vanessa Hampton and Alan Minsk (Arnall Golden Gregory)

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Strong Stakeholder Support for PDUFA 8

Bipartisan Policy Center Comment on Generative AI Devices

Improve FDA Myelodysplastic Syndromes Guidance

Court Rejects FDA HCT/P Designation