Report: FDA’s 510(k) process is “flawed”, beyond repair, just start over

 
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 ...