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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...

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The U.S. Food and Drug Administration (FDA) has released a draft guidance detailing the...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

FDA Releases 510(k) Third-Party Performance Metrics

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

FDA Warns of Potential Effects of Magnets in Cell Phones and Smartwatches

The U.S. Food and Drug Administration (FDA) is advising consumers with embedded pacemakers and...

FDA Reverses HHS Action to Exempt Certain Medical Devices from 510(k) Requirements

The U.S. Food and Drug Administration (FDA) has withdrawn a January proposal by the...

FDA Authorizes 50+ Testing Labs for Conformity Testing Pilot

The U.S. Food and Drug Administration (FDA) has now accredited more than 50 testing...
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