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U.S. Food and Drug Administration (FDA)

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...

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...

Batteries in Implantable Defibrillators May Fail

The U.S. Food and Drug Administration (FDA) and medical device manufacturer St. Jude Medical...
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FDA Updates Draft Recommendations for 510(k) Device Modifications

The U.S. Food and Drug Administration (FDA) has issued an updated draft guidance to...

FDA Issues New UDI Draft Guidance

The U.S. Food and Drug Administration (FDA) has issued a new draft guidance on...

FDA Seeks Comments on 3D Printing for Medical Devices

The Food and Drug Administration (FDA) is now accepting comments and suggestions on a new draft guidance for medical device manufacturers working with additive manufacturing, commonly known as 3D printing.

FDA Proposes Ban on Electrical Stimulation Devices for Behavioral Conditioning

The U.S. Food and Drug Administration (FDA) has proposed a ban on electrical stimulation...

FDA Approves Motorized Leg Braces

The U.S. Food and Drug Administration (FDA) has approved a medical device that functions...
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