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Medical Devices / Regulatory Affairs

Industry Reps Cite Tight Timeline for MDUFA IV

April 11, 2017
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The FDA will have to issue potential layoff notices to about 500 reviewers of medical devices if lawmakers fail to reauthorize user fees by the end of July, industry representatives told the Senate’s health committee.

Scott Whitaker, president and CEO of AdvaMed, praised “ground-breaking” process improvements in the MDUFA III agreement, which he said allowed the FDA to reduce its total time to decision for product submissions while maintaining strong safety and effectiveness standards.

He said MDUFA IV will build on those improvements by making the device review process more predictable, consistent, accountable, and timely.

However, Whitaker and representatives from BIO, the Association for Accessible Medicines, and the Alliance for Aging Research expressed concern over the limited time left for Congress to act on user fees.

The committee hopes to move user fee reauthorization to the Senate floor by the end of April, and the current user fee programs expire at the end of September.

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