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medical devices

Commission Issues Corrections on MDR and IVDR

The Commission of the European Union (EU) has issued two “Corrigendums” in connection with...

FDA Issues Guidance on Premarket Submission Info on Performance Testing

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

U.S. FDA Issues Guidance on Medical Devices Containing Materials of Animal Origin

The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug...

FDA Issues Guidance on Device Exemptions from Pre-Market Notification Requirements

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

U.S. FDA Releases Guidance on Expansion of Abbreviated 510(k) Program

Despite the month-long partial shut-down of the U.S. federal government, the Food and Drug...
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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...

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...

FDA Releases Draft Guidance of Medical Device Cybersecurity

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