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medical devices

UK Seeks Overhaul of AI, Software as a Medical Device

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

UK MHRA Launches Med Device Regulatory Consultation

The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a public...

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...

EU Commission Updates Harmonized Standards for In Vitro Devices

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

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The U.S. Food and Drug Administration (FDA) has released a draft guidance detailing the...

FDA Seeks Budget Increase, Especially for Medical Device Review

The U.S. Food and Drug Administration (FDA) is seeking an increase of over $550...
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