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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...

ANSI HAC Standard Now Recognized by the FDA and FCC

In some good news for those with impaired hearing, the U.S. Food and Drug...
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FDA Publishes Principles for AI and ML in Medical Devices

Medical device regulatory agencies in the U.S., Canada, and the United Kingdom have recently...

FDA Takes Steps to Ease Access to OTC Hearing Aid Devices

The U.S. Food and Drug Administration (FDA) is taking action to ease public access...

FDA Offers Best Practices for Alerting About Cyberthreats

As concerns about cybersecurity become part of the everyday threat landscape, the U.S. Food...

FDA Issues Draft Guidance on 510(k) Electronic Submission Template

The U.S. Food and Drug Administration (FDA) has issued a draft guidance to further...

FDA Publishes List of Approved AI/ML-Enabled Medical Devices

The U.S. Food and Drug Administration (FDA) has published its first list of authorized...
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