The Institute of Medicine’s Broad Recommendations for Replacing the 510(k) Clearance Process

On July 29, 2011, the Institute of Medicine of the National Academy of Sciences released its eagerly awaited report titled, “The FDA 510(k) Clearance Process at 35 Years.” The FDA had asked the Institute of Medicine (“IOM”) to answer two specific questions: 1) Does the current 510(k) clearance process optimally protect patients and promote innovation in support of public health?; and 2) if not, what legislative, regulatory, or administrative changes are recommended to optimally achieve the goals of the 510(k) clearance process? The IOM committee charged with answering these questions has produced a sweeping set of recommendations, advocating the replacement of the 510(k) clearance process1 and major changes in the way the FDA regulates and monitors medical devices. As broad as the IOM’s recommendations are, they are equally short on detail, so it remains to be seen what influence the report will ultimately have on medical device regulation in the United States. Nevertheless, the IOM’s call for major changes is likely to lend significant momentum to efforts by groups both within and outside of the industry to reform the FDA’s approach to regulating medical devices.

The most surprising conclusion of the IOM report is that the 510(k) process is “not intended to evaluate the safety and effectiveness of medical devices” and “cannot be transformed into a premarket evaluation of safety and effectiveness as long as the standard for clearance is substantial equivalence to any previously cleared device.” Dr. David Challoner, chairman of the IOM committee, summarized this conclusion more succinctly, calling the 510(k) clearance process “fatally flawed.”2 The committee attacked the substantial equivalence standard by claiming that, in practice, the assessment of substantial equivalence “generally does not require evidence of safety or effectiveness of a device.” The IOM committee also noted that many of the medical devices that serve as predicate devices, to which substantial equivalence must be demonstrated, were themselves never reviewed for safety or effectiveness and pointed to the lack of good post marketing information on the safety and effectiveness of these predicate devices. The impact of this statement is startling, especially since the same committee explicitly acknowledged it “does not believe . . . that there is a public-health crisis related to unsafe or ineffective medical devices.”