In a previous post, I discussed the FDA’s Center for Devices and Radiological Health (CDRH) re-evaluation of the 510(k) review process for medical devices.  This re-evaluation, spearheaded by the very visible director of CDRH, Dr. Jeffrey Shuren, was prompted by industry complaints about the review process, arguments over the safety of cleared devices, and a silverscreen-worthy saga resulting in the bankruptcy of a medical device firm and the ousting of the previous CDRH head.  The re-evaluation process included both an extensive internal review by CDRH itself and an independent review by an Institutes of Medicine (IOM) committee composed of former FDA personnel, physicians, professors of law, an expert on information technology, and an insurance industry representative.  The internal review has been an ongoing effort but the external review culminated in last Friday’s much-anticipated official release of the IOM committee’s report titled “Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years.” Continue reading →