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Aptalis, a specification developer for the Flutter mucus clearance device, failed to report a contract manufacturer’s rework of devices to correct issues both this year and in 2012, a recent FDA warning letter says. Read More
CDRH plans to roll out 12 final guidance documents in fiscal 2014, including guidances on cybersecurity, the device appeals process and the global unique device identification database, or GUDID, the center revealed Thursday. Read More
The FDA has released a previously announced warning letter to spine implant maker Globus Medical, citing the company for releasing five lots of MicroFuse putty that did not meet its own specification for mechanical testing. Read More