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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...

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...
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FDA Releases Draft Guidance of Medical Device Cybersecurity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U.S. FDA Issues Draft Guidance on Special 510(k) Program

The U.S. Food and Drug Administration (FDA) has published a draft guidance intended to...

FDA Streamlines Device Malfunction Reporting

As part of its effort to streamline the process for reporting malfunctioning medical devices,...

U.S. FDA Launches Pilot Program to Expedite 510(k) Applications

The U.S. Food and Drug Administration (FDA) has launched a new pilot program intended...
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