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The latest agreement includes higher fees for overseas firms, hiring transparency requirements and greater use of real-world evidence.
Elise Reuter, MedTech Dive, August 10, 2026
U.S. companies will see few changes from the latest Medical Device User Fee Amendments, but overseas firms will face higher costs than under the current five-...
August 7, 2026
Re: Docket No. FDA-2026-N-6655 for “Medical Device User Fee Amendments; Public Meeting; Request for Comments.”
We appreciated the opportunity to participate in the MDUFA Stakeholders meetings. As representatives of patient, consumer, health, and public interest organizations that do not receive funding from medical device compani...
August 7, 2026
Re: Docket No. FDA-2026-N-6655 for “Medical Device User Fee Amendments; Public Meeting; Request for Comments.”
We appreciated the opportunity for Dr. Diana Zuckerman, President, National Center for Health Research, to serve on the patient and consumer panel at the MDUFA VI meeting on August 5, 2026, and want to more fully explain ...