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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...

FDA Issues Updated EMC Guidance for Medical Devices

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

FDA Expands Efforts to Accredit Testing Laboratories Under ASCA Pilot Program

The U.S. Food and Drug Administration (FDA) is ramping up its efforts to expand...

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...
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FDA Updates Data on Breakthrough Device Program

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

Senate Introduces Medical Device Security Act

The U.S. Senate has introduced a bipartisan measure that would help to ensure the...

FDA Clarifies Cybersecurity Recommendations for Medical Devices

The U.S. Food and Drug Administration (FDA) has issued an updated draft guidance that...

FDA Warns of Medical Device Cyber Vulnerabilities

The U.S. Food and Drug Administration (FDA) has issued an alert to medical device...

FDA Releases Final Guidance on Voluntary Recalls

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