Devices

FDA, Device Industry Reach Agreement on MDUFA VI

FDA and the medical device industry are nearing a final agreement on the next round of Medical Device User Fee Act (MDUFA VI) negotiations, according to a MedTech Dive report. Both sides have reached an “agreement in principle” on most elements of the deal and are now working to finalize a commitment letter that will be submitted to Congress for approval. The agreement will set user fee funding and performance goals for the agency’s device program from 2027 through 2032.

A central focus of the negotiations has been staffing at CDRH, which has faced resource constraints following broader workforce reductions at HHS. FDA says it plans to hire “substantial numbers” of additional review staff under the new agreement, building on hiring commitments made in the current MDUFA V program.

Industry stakeholders have pushed for assurances that staffing levels supported by prior user fees will be maintained, while the FDA has indicated that MDUFA VI will include incremental increases in staffing and operational funding.

The negotiations also address policy issues such as the use of real-world evidence and potential changes to annual establishment fees. Among the proposals is a plan to charge higher registration fees to foreign device manufacturers compared with domestic firms, reflecting what officials describe as an “America-first” approach to strengthening U.S. supply chains and innovation.

FDA says that, under the proposed framework, most companies could see lower overall fees by fiscal year 2028 due to adjustments in the statutory fee structure, including reduced submission and domestic registration fees, according to the report.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome