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The U.S. Food and Drug Administration (FDA) has released a draft guidance detailing the...

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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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 Authorizes 50+ Testing Labs for Conformity Testing Pilot

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

FDA Releases Catalog of Regulatory Science Tools for Medical Devices

To facilitate the expanded use of innovative science techniques in the development of new...

FDA Posts Biocompatibility Resource Center

The U.S. Food and Drug Administration (FDA) has collected a variety of resources to...

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