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There has been a steady uptick in the number of FDA 483s that cite inadequate supplier controls — from 84 in 2011, to 110 in 2012 and 126 last year. The problem is now one of the top five most common 483 findings for devicemakers. Read More
CINCINNATI — Only devices that violate the 1938 FD&C Act should be labeled Import for Export, FDA officials cautioned at the recent FDA/Xavier University MedCon conference. Read More
CINCINNATI — With September’s deadline for displaying unique device identifiers on high-risk devices just around the corner, rollout for many manufacturers is well underway. Read More
The FBI has warned healthcare providers to expect an upsurge in cybercrimes against health information systems and to make sure medical devices aren’t causing vulnerabilities in their networks. Read More
As the July 22 deadline for complying with new EU requirements on hazardous substances approaches, some manufacturers of medical devices and active implantable medical devices are feeling a financial squeeze. Read More
The FDA’s Denver office will host a two-day public workshop on global drug and device safety during an educational conference sponsored by the Association of Food and Drug Officials. Read More