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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...

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FDA Issues Draft Guidance on 510(k) Electronic Submission Template

The U.S. Food and Drug Administration (FDA) has issued a draft guidance to further...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

FDA Offers Online Tracker for Premarket Submissions

The U.S. Food and Drug Administration (FDA) now has a secure web-based tracking system...

FDA Releases Discussion Paper on Medical Device Cybersecurity Challenges

The U.S. Food and Drug Administration (FDA) has released a discussion paper on specific...

FDA Extends Comment Period on Remanufacturing of Medical Devices Guidance

The U.S. Food and Drug Administration (FDA) has extended the public comment period on...

FDA Releases Guidance on UDI Systems for Medical Devices

The U.S. Food and Drug Administration (FDA) has published a Final Guidance on the...
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