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FDA Releases Final Guidance on Voluntary Recalls

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

Industry Groups Call for 2-Year Extension of MDR Transition Period

Two leading medical industry groups in the European Union (EU) are calling on the...

FDA to Amend Medical Device Quality System Regulation

The U.S. Food and Drug Administration (FDA) has requested public comment on its plan...

EU Commission Extends Transitional Provisions for In Vitro Diagnostics

The Commission of the European Union (EU) has amended key transitional provisions for certain...

FDA Updates 510(k) Third-Party Performance Metrics

The U.S. Food and Drug Administration (FDA) has published its most recent data on...

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Medical Devices Increasingly Vulnerable to Cyberattacks

Despite ongoing publicity around the need to secure systems and equipment against the threat...

EU Commission Updates Biological Safety Standards Applicable under MDR

The Commission of the European Union (EU) has updated the list of standards that...

FDA Publishes Discussion Paper on 3D Printing of Medical Devices

The U.S. Food and Drug Administration (FDA) has released a discussion paper on the...

EU Commission Regulates Electronic Instructions for Medical Device Use

The Commission of the European Union (EU) has also published requirements for providing medical...

FDA Updates List of Recognized Standards for Medical Devices

The U.S. Food and Drug Administration (FDA) has updated its list of recognized international...

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Military and Aerospace EMC: High Intensity Radiated Fields (HIRF)

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