Image of U.S. Capitol home of Congress including U.S. House and Senate considering medical device user fees
[Image from Unsplash]

The U.S. House last night voted 392-28 to pass Medical Device User Fee Amendments that reflect the latest agreement between the FDA and the medtech industry.

The House bill on FDA amendments that passed, sponsored by Rep. Ann Eshoo (D-California), drew from the MDUFA V agreement between the FDA and medical device industry. It reauthorized the FDA user fee programs for prescription drugs, medical devices, generic drugs and biosimilar through the fiscal year 2027. It also required the development of action plans and related reporting to increase the diversity of participants in clinical trials.

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