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ASCA 2024 Performance Update: Can ASCA Improve Submission Predictability?

Summary by FDA Law Blog
In January 2025, FDA posted the 2024 Annual Report concerning the Accreditation Scheme for Conformity Assessment (ASCA) program as required by Medical Device User Fee Amendments of 2017 (MDUFA IV).…
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ASCA 2024 Performance Update: Can ASCA Improve Submission Predictability?

In January 2025, FDA posted the 2024 Annual Report concerning the Accreditation Scheme for Conformity Assessment (ASCA) program as required by Medical Device User Fee Amendments of 2017 (MDUFA IV).…

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FDA Law Blog broke the news in on Tuesday, April 15, 2025.
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