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Medical Devices

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...

UK Seeks Overhaul of AI, Software as a Medical Device

In the wake of its exit from the European Union, the United Kingdom is...

EU Commission Updates List of Harmonized Standards for MDR

The Commission of the European Union (EU) has updated its list of harmonized standards...

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...
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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...

FDA Issues Guidance on Remanufacturing of Medical Devices

The U.S. Food and Drug Administration (FDA) has released a draft guidance detailing the...

The EU’s MDR is Now in Effect

The European Union’s (EU’s) new regulation for medical devices sold or imported into the...

FDA Releases 510(k) Third-Party Performance Metrics

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