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medical devices

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...

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...
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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...

FDA Updates List of Recognized Standards

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

FDA Clarifies “Refuse to Accept” Policy for 510(k) Submissions

The U.S. Food and Drug Administration (FDA) has issued an updated guidance to explain...

FDA Updates Data on Breakthrough Device Program

The U.S. Food and Drug Administration (FDA) reports that it has granted more than...
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