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medical devices

FDA Issues Draft Guidance on Human Factors Information in Medical Device Submissions

The U.S. Food and Drug Administration (FDA) has issued a draft guidance intended to...

FBI Recommends Actions to Protect Medical Devices from Cyberattacks

The U.S. Federal Bureau of Investigation (FBI) has issued a report detailing the potential...

FDA Releases Draft Guidance on Production and Quality System Software

The U.S. Food and Drug Administration (FDA) has released draft guidance intended to help...

FDA Underfunding May Be Impacting Medical Device Cybersecurity Protections

Insufficient funding and a lack of trained personnel at the U.S. Food and Drug...

FDA Updates Recognized Standards List

The U.S. Food and Drug Administration (FDA) has updated its list of recognized international...
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FDA Launches New Premarket Submissions Tracker

The U.S. Food and Drug Administration (FDA) has now made available an online platform...

MDSAP Extends Remote Auditing Option

The International Medical Device Regulators Forum (IMDRF) has temporarily extended the limited use of...

EU Commission Sets Criteria for Reference Labs under the IVDR

The Commission of the European Union (EU) has recently detailed the criteria and tasks...

FDA Issues Updated EMC Guidance for Medical Devices

The U.S. Food and Drug Administration (FDA) has finalized its guidance on electromagnetic compatibility...

EU Commission Updates Harmonized Standards for Quality Management in Medical Devices

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