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In a rare exception to the FDA’s normal practice, the agency posted a Form 483 flagging several GMP and MDR nonconformities — most of which are repeat observations — at a Zimmer Biomet medical device manufacturing facility in Indiana. Read More
A four-day FDA inspection of Curasan’s manufacturing facility in Frankfurt, Germany revealed a lack of manufacturing and adverse event reporting procedures. Read More
The FDA said the Banyan Brain Trauma Indicator has the potential “to rule out the need for a CT scan in at least one-third patients who are suspected of having mTBI.” Read More
The FDA cited seven U.S. devicemakers and one in Japan for various noncompliances with regulatory requirements, including inadequate complaint investigations. Read More
Boston Scientific is facing regulatory hurdles with its proposed manufacturing process and design changes to bring its transcatheter aortic valve back to the U.S. and EU markets. Read More