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FDA Provides Pre-Certification Working Model

The partial shutdown of many federal agencies has apparently not stopped the U.S. Food...

U.S. FDA Posts MDSAP Stakeholder Presentations

The U.S. Food and Drug Administration (FDA) has now provided access to presentations from...

FDA Proposes Improvements in De Novo Pathway for Medical Devices

The U.S. Food and Drug Administration (FDA) has issued a proposed rule intended to...

FDA Issues Final Guidance on Manufacturing Site Changes

The U.S. Food and Drug Administration (FDA) has issued a final guidance intended to...

FDA Issues Final Rule on Medical Device Classifications

The U.S. Food and Drug Administration (FDA) has published a final rule that brings...
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U.S. FDA Issues Updated Guidance on Medical Device UDI Compliance

The U.S. Food and Drug Administration (FDA) has issued an updated Guidance on its...

High Exposure to RF Radiation Linked to Cancer in Rats

A recently published scientific study may have given new life to decades-old concerns about...

FDA Releases Draft Guidance of Medical Device Cybersecurity

The U.S. Food and Drug Administration (FDA) has issued a series of recommendations for...

U.S. FDA Issues Final Guidance on Substantial Equivalence

The U.S. Food and Drug Administration (FDA) has issued a final guidance to help...

U.S. FDA Issues Draft Guidance on Special 510(k) Program

The U.S. Food and Drug Administration (FDA) has published a draft guidance intended to...
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