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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
Devicemakers saw an increase in 2013 in the number of FDA 483s that cite inadequate supplier controls; the finding is now one of the top five most common 483 findings for devicemakers. Read More
The China Food and Drug Administration has unveiled long-awaited reforms to its medical device regulations, extending the life of product licenses, but imposing first-time fees for device registrations. Read More
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
The FDA has closed out a warning letter issued to online genetics testing firm 23andMe, following the company’s agreement to take its health-related tests off the market. Read More