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FDA Proposes Exempting Some Class II Devices from 510(k) Requirements

The U.S. Food and Drug Administration (FDA) has proposed exempting several hundred medical devices...

FDA Issues Final Guidance on Medical Device Cybersecurity

The U.S. Food and Drug Administration (FDA) has issued a final version of its...

FDA Issues Final Rule for Post-Market Safety Reporting for Combination Products

The U.S. Food and Drug Administration (FDA) has issued a Final Rule that establishes...

Medical Device Recalled Due to Electrical Issues

The U.S. Food and Drug Administration (FDA) is reporting the voluntary recall of certain...

FDA Issues Guidance on Sale of Non-Prescription Hearing Aids

The U.S. Food and Drug Administration (FDA) has announced plans to improve consumer access...
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FDA Proposes Labeling Submission Rules for Some Home-Use Medical Devices

In an effort to make information on the use of certain higher-risk home-use medical...

Ventricular Assist Device Pumps Recalled

HeartWare is recalling its Ventricular Assist Device (HVAD) with serial numbers lower than HW25838. A design problem...

Batteries in Implantable Defibrillators May Fail

The U.S. Food and Drug Administration (FDA) and medical device manufacturer St. Jude Medical...

Surgical Power Tool Battery Adaptors Recalled

DePuy Synthes is recalling the Adaptor and Light Adaptor for Small Battery Drive and...

FDA Updates Draft Recommendations for 510(k) Device Modifications

The U.S. Food and Drug Administration (FDA) has issued an updated draft guidance to...
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