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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...

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FDA Releases Draft Guidance of Medical Device Cybersecurity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U.S. FDA Issues Draft Guidance on Special 510(k) Program

The U.S. Food and Drug Administration (FDA) has published a draft guidance intended to...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

FDA Seeks Comment on Class 1 Accessories

The U.S. Food and Drug Administration (FDA) is seeking public comment on a proposed...
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