IOM to FDA: Medical device clearance not cutting it anymore

The U.S. Food and Drug Administration should replace its 35-year-old 510(k) clearance process for medical devices, says a new report issued by the Institute of Medicine. “The committee found that the 510(k) program lacks the statutory basis to make it a reliable premarket screen for safety and effectiveness of Class II medical devices,” the IOM committee wrote in its report.

"It's not clear that the 510(k) process is serving the needs of either industry or patients, and simply modifying it again will not help," said committee chair David Challoner, emeritus vice president for health affairs, University of Florida, Gainesville, in a press release about the report....

..."The 510(k) process cannot achieve its stated goals – to promote innovation and make safe, effective devices available to patients in a timely manner – because they are fundamentally at odds with the statutes that govern how FDA must implement the process. While current information is not adequate to immediately start designing a new framework, we believe the agency can get the necessary data and establish a new process within a reasonable time frame," said Challoner...