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medical devices

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...

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The U.S. Food and Drug Administration (FDA) has released a draft guidance detailing the...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

FDA Issues Guidance on Medical Device Safety in MRI Facilities

The U.S. Food and Drug Administration (FDA) has issued its final guidance on assessing...

The EU’s MDR is Now in Effect

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