Lifting The Hood On MDUFA V
The document includes promises from the US FDA related to review timelines, consensus standards, the Total Product Life Cycle pilot, and more.
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Medcon 2023: Shuren Mulls New Pathway For Digital Devices
The head of the US FDA’s Center for Devices and Radiological Health said that an optional new pathway could help the agency regulate the flood of novel devices intended for at-home use. His presentation also touched on MDUFA V implementation, post-pandemic strategy, and CDRH staffing needs.
FDA Asks For Input On Best Ways To Support Premarket Use Of Real-World Evidence
The US Food and Drug Administration is seeking public comment on how best to allocate funds authorized under the latest installment of the Medical Device User Fees Amendments to support premarket real-world evidence.
Deal Reached On FDA User Fee Renewal
Committee leaders in the US Congress have agreed on a stripped-down path to user fee reauthorization, which will not include FDA oversight of diagnostic tests.