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BioWorld - Tuesday, December 16, 2025
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Home » FDA draft for third-party EUA reviews lacks timeline commitments
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FDA draft for third-party EUA reviews lacks timeline commitments

Jan. 30, 2024
By Mark McCarty
The U.S. FDA has redrafted an existing guidance for third-party reviews of 510(k) submissions to include submissions under the emergency use authorization (EUA) program, which generally speaking should be good news. The problem with the draft is that these third parties will have to interact frequently and substantively with the FDA in EUA reviews, and the lack of prescribed timelines in the FDA draft suggests that while the use of third parties may help the agency manage any future EUA workloads, the total turnaround time for these applications might not be significantly better than was seen during the COVID-19 pandemic.
BioWorld MedTech Regulatory U.S. FDA

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