U.S. Food and Drug Administration (FDA)

FDA Issues Guidance on Medical Device Cybersecurity

As part of it overall effort to ensure the safety of patients, the U.S....

FDA Reopens Public Comment on Hearing Aid Guidance

The U.S. Food and Drug Administration (FDA) has reopened a public comment period on...

Boston Scientific Recalls Device Used in Vascular Procedures

Boston Scientific has issued a global voluntary recall of its Chariot-brand guiding sheath, a...

Recall of Sterile Compounded Products

An Arkansas medical compounding company has announced a nationwide recall of all lots of...

Company Notifies Hospitals of Ventricular Assist Device Issues

A California medical device manufacturer has issued a voluntary Urgent Medical Device Correction Letter...

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EMC Bench Notes: Pre-Compliance Testing for Radiated Emissions, Part 4 – Measurement Software

FDA Classifies Radiofrequency Toothbrush as Medical Device

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