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C.R. Bard received an FDA Form 483 for storage area control and other manufacturing issues. The company had not performed temperature mapping studies to find “cold spots, hot spots, dead spots.” Read More
Beginning this month, all devicemakers holding CE certificates for devices classified as Class IIa and above should be prepared for unannounced quality system visits by notified body inspectors. Read More
Hospira will pay $60 million to settle a class-action lawsuit that claimed the company misled investors about its quality problems, under a plan tentatively approved in federal court. Read More
The first head-to-head comparison of Edwards and Medtronic transcatheter aortic valve replacement (TAVR) technologies ended with a win for Edwards. Read More
Beginning this month, all devicemakers holding CE certificates for devices classified as Class IIa and above should be prepared for unannounced quality system visits by notified body inspectors. Read More
The FDA last month approved St. Jude Medical’s Allure Quadra Cardiac Resynchronization Therapy Pacemaker (CRT-P), Assurity pacemaker and Endurity pacemaker families of devices. Read More
Abbott Vascular received an FDA Form 483 because its Temecula, Calif., facility did not have a procedure defining storage conditions for certain biological indicators. Read More
Radlink, a Gardena, Calif., devicemaker, was handed a Form 483 for lacking a “clear agreement with suppliers and contractors” on notification before changes to products or services. Read More