IOM Calls 510(k) Process "Flawed", Recommends FDA Develop New System (written by Lauren Uzdienzki @ HealthPointCapital)
The long-awaited IOM report on the 510(k) framework was released this morning, and, not unexpectedly, the IOM found flaws in the system. Less expected was the recommendation that the 510(k) was beyond repair and the FDA should just start over.
One of the committee's main findings was that the 510(k)'s substantial equivalence requirement does not prove safety and efficacy. As such, the group recommends that the 510(k) program be scrapped in favor of a system that does reasonably assure safety and efficacy. They say this transition should occur as quickly as possible, even noting the time it would take to design a new system. This is emphasized in an accompanying letter from the committee to CDRH director Jeff Shuren, wherein the IOM advised the FDA not allocate their "sparse resources" on revamping the 510(k), but instead focus on developing a more "rational" system. The report also made a case for heightened post-market surveillance and an initiative to assess whether its regulatory pathway for class II devices was hindering innovation.
While the IOM report...
