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U.S. Food and Drug Administration (FDA)

FDA Exempts 70 Plus Class I Devices from 510(k) Premarket Notification

The U.S. Food and Drug Administration (FDA) has identified an extensive list of Class...

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...
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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...

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The U.S. Food and Drug Administration (FDA) has issued an updated draft guidance to...

FDA Issues New UDI Draft Guidance

The U.S. Food and Drug Administration (FDA) has issued a new draft guidance on...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