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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...

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The U.S. Food and Drug Administration (FDA) has issued an updated draft guidance that...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

FDA to Amend Medical Device Quality System Regulation

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

FDA Updates 510(k) Third-Party Performance Metrics

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

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...

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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