MDCI’s own Rosina Robinson, RN, M.Ed., RAC, and Principal Consultant, will be presenting a webinar tomorrow through Thompson Interactive entitled “New Updates on the 510(k): The IOM Report.” This webinar touches on the subject of yesterday’s MDCI blog post discussing the IOM report’s recommendations that the current 510(k) process be scrapped in favor of an … continue reading

The medical device industry has found itself in an uproar over a July 29, 2011 report that was issued by the Institute of Medicine (IOM) regarding the 510(k) program.  The report, which was commissioned by the FDA in 2009, included strong statements concerning the current 510(k) process.  The intent of the FDA when it commissioned … continue reading