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U.S. Food and Drug Administration (FDA)

FDA Approves “Smart” Contact Lens Medical Device

The U.S. Food and Drug Administration (FDA) has approved the marketing of a one-time...

St. Jude Medical Device Recall Gets FDA Class 1 Status

The U.S. Food and Drug Administration (FDA) has reclassified as a Class 1 Advisory...

FDA Identifies Priority Medical Devices for Human Factors Review

The U.S. Food and Drug Administration (FDA) is soon likely to require human factors...

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...
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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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