FDA rejects IOM device recommendation

FDA said Friday it would not implement an Institute of Medicine committee's recommendation to scrap the 510(k) process, which allows marketing of Class II medical devices based on their substantial equivalence to already cleared devices. In a report commissioned by the agency, the committee said the 510(k) process lacks the legal basis to be a reliable premarket screen of safety and effectiveness "and cannot be transformed into one." The report did not specifically address molecular diagnostics or laboratory-developed tests (LDTs), but its recommendations would apply to some diagnostics. ...