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FDA’s CDRH Seeking Customer Feedback

The U.S. federal agency responsible for the regulation and oversight of medical devices is...

Medical Device Cybersecurity Guidelines Released

The Food and Drug Administration has announced guidelines for cybersecurity for medical device manufacturers....

Recalled Medical Product Lacked FDA 510(k) Approval

In conjunction with the U.S. Food and Drug Administration (FDA), ConvaTec, Inc. has initiated...

Voluntary Recall of Breast Pump AC/DC Power Adapters Expanded

Playtex Manufacturing, Inc. added a production lot to a March 2014 voluntary recall of...

TIA Commends New FDA Approach to Medical Device Data Systems

The Telecommunications Industry Association (TIA) submitted comments to the Food and Drug Administration (FDA)...

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Medical CO2 Detectors Recalled

GE Healthcare, LLC, of Waukesha, WI has issued a recall of certain models of...

Infusion Pump Manufacturer Announces Corrective Action

Hospira, Inc. of Lake Forest, IL has issued an urgent correction notice in connection...

Medical Device Recalls Double in Past Decade

The number of recalls of defective medical devices has nearly doubled within a ten...

New Medical Device Available to Prevent Migraine Headaches

The U.S. FDA has approved the first device as a preventative treatment for migraine headaches. The device is a small, portable, battery-powered device that looks similar to a plastic headband that is worn across the forehead and on top of the ears prior to the onset of pain.

Blood glucose meters recalled

Nipro Diagnostics, Inc. has announced a voluntary recall of certain models of its blood...

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Product Insights: The Sources of Uncertainty in Radiated Emissions Tests

FDA Issues Pilot Program to Enhance Medical Device Recalls

FCC Issues Final Rules for Program-Originating FM Boosters

Practical Engineering: Odds and Ends – Navigating the Nuances of Compliance Engineering

FDA Issues Guidance on Third-Party Review Program