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The FDA is reopening the public comment period on a 2010 draft guidance on infusion pumps, highlighting its adjusted time estimate for manufacturers to submit case assurance reports. Read More
Attorneys for Ivy Sports Medicine told a federal judge Tuesday that the FDA did not have authority to reconsider and rescind a classification decision on ReGen Biologics’ Menaflex collagen scaffold device. Read More
In a bid to cut down on orphan medical device developers wasting agency time, the FDA is outlining new, detailed guidelines for what constitutes a legitimate topic for formal and informal presubmission meetings. Read More
European regulators have granted Edwards Lifesciences’ next-generation Intuity Elite valve system CE Mark approval, the Irvine, Calif., devicemaker said Friday. Read More
The FDA has finalized a guidance on interactive reviews to include commitments it made in the MDUFA III commitment letter and to expand use of the process. Read More
“Accurate detection … is critically important in efforts to successfully detect and potentially reduce the incidence of cervical cancer,” Cepheid CEO John Bishop says. Read More