Industry Expects GAO Report to Challenge 510(k) Program

A forthcoming report examining the FDA’s 510(k) program is expected to be critical and will likely re-categorize Class II devices. Although the Government Accountability Office’s findings on the 510(k) process will not be released until later this year, the device industry is confident the report will be negative and will recommend changes, Pat Schrader, Becton Dickinson’s senior vice president of Regulatory & External Affairs, said. The FDA has identified more than 2,300 medical devices, from syringes to catheters, as Class II devices. Since Class II constitutes such a broad range of products with differing risk levels, industry expects the report will recommend dividing the class.