IOM urges FDA to scrap 510(k) device-clearance process

The expedited 510(k) process, in which some medical devices are cleared by the Food and Drug Administration, is flawed and Congress should enact legislation for a new regulatory framework to be developed in its place, according to a highly anticipated report from the Institute of Medicine.

The IOM committee recommended that Congress pass legislation once the FDA gathers needed information to design the new system.

“Rather than continuing to modify the 35-year-old 510(k) process, the committee concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and post-market regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle,” the authors wrote.

The FDA, as well as the Advanced Medical Technology Association, which represents device makers, and the Medical Imaging and Technology Alliance said in separate statements that they do not support the IOM’s recommendation to scrap the 510(k) process.

Click here to read the full article