06-August-2011

The Institute of Medicine's recent recommendation that the U.S. Food and Drug Administration eliminate the 510(k) clearance process for medical devices lacks a process for enhancing patient safety and threatens to create economic distress in the industry, according to the editorial in the Star Tribune of Minneapolis, "The Wrong Prescription on Medical Devices."

The 510(k) pathway allows medical devices similar to existing products to be approved through a less rigorous process than new devices. Two years ago, the FDA asked the Institute of Medicine to help strike the best balance on 510(k) between patient safety and industry concerns, the editorial reported. In July 2011, the panel concluded that the process "lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk devices and … cannot be transformed into one."

However, the Star Tribune staff maintains that the report fails to make a safety-based case for eliminating the 510(k) process. The Institute of Medicine did not answer some of the FDA's specific questions about process improvements and didn't outline what the replacement process would be. Furthermore, the report admitted that continued use of these devices provides reason for "a level of confidence in their safety and effectiveness."

Ralph Hall, advisor at B&D; Consulting and University of Minnesota Law School professor, agrees that the process has proven its safety and effectiveness. He provided the Star Tribune with recall data showing that just 0.45 percent of 510(k) clearances from 2005 to 2009 were subject to Class I recalls, the FDA's most serious recall category. That figure drops to 0.22 percent when only premarket issues are considered. (Postmarket issues, such as manufacturing defects, likely wouldn't have been prevented by scrutiny before the device's sale).

The report's conclusion also amplifies the unknowns in the device industry, which provides well-paying jobs in Minnesota and across the nation. Eliminating the 510(k) process would make it more difficult for the industry to attract venture capital and would encourage more research and development jobs to be moved offshore — something documented by a PricewaterhouseCoopers report earlier this year.