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The FDA’s draft guidance on cybersecurity for devices is a good start but needs some clarification, according to a working group of the International Organization for Standardization (ISO) and a variety of devicemakers. Read More
Inadequate corrective and preventive action (CAPA) and training procedures landed Phoenix Diagnostics with a Form 483 after the FDA inspected the company’s Natick, Mass., facility in March. Read More
Germany’s Federal Institute for Drugs and Medical Devices released a notice showing that multiple Medtronic heart devices are being recalled in Europe due to reduced shock energy. Read More
Craftmatic Industries received a Form 483 for repeated problems with product quality and complaint-reporting issues observed in an FDA inspection of its Pompano Beach, Fla., facility earlier this year. Read More