The U.S. Food and Drug Administration is reportedly looking to overhauling the pipeline for medical device approvals in a bid to modernize and streamline the pathway for high-tech innovations, FierceHealthcare reports.
The agency is looking to make the changes to the 510(k) pathway, a process for device approvals introduced 40-plus years ago, according to the report.
Some 82 percent of all medical devices in 2017 were cleared through the 510(k) pathway, and officials say they are “seizing the chance to make a generational change in the framework for 510(k) reviews.”
“We believe firmly in the merits of the 510(k) process,” FDA Commissioner Scott Gottlieb and Center for Devices and Radiological Health Director Jeff Shuren said in a statement. “But we also believe that framework needs to be modernized to reflect advances in technology, safety and the capabilities of a new generation of medical devices.”