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Home » Shuren: Routine premarket review of IVDs will lag for the balance of 2021
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FDA/Xavier Medcon Conference

Shuren: Routine premarket review of IVDs will lag for the balance of 2021

May 6, 2021
By Mark McCarty
The FDA’s operations have been badly hampered by the COVID-19 pandemic, but Jeff Shuren, director of the agency’s Center for Devices and Radiological Health (CDRH), said review times for most non-COVID product categories should resume their normal clip by the end of 2021. However, he acknowledged that the lag for in vitro diagnostics (IVDs) may not be fully resolved until 2022 because of the resources needed to review emergency use authorizations for tests for the SARS-CoV-2 virus.
BioWorld MedTech Conferences Regulatory Coronavirus Diagnostics U.S. FDA

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