In a damning evaluation of the US Food and Drug Administration’s 510(k) program, which is used to clear medical devices similar to those approved previously, the US Institute of Medicine (IOM) issued a report on 29 July calling for a complete overhaul of the 35-year-old device regulation system. The IOM’s conclusions harshly criticized the 510(k) process for clearing new devices on the basis of their similarity to existing products without evaluating safety and effectiveness data. But the 245-page report committed a mere two pages to what some consider an equally insidious problem affecting the approval of some kinds of medical devices: the review of combination products that straddle the divide between a device and a small-molecule– or biologic–based drug.

“We’d like to see the FDA be proactive in however it approaches combination and companion products,” says IOM panel member Steven Gutman, a pathologist who directed the FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety for six years and now serves as associate director of the BlueCross and BlueShield Association’s Technology Evaluation Center in Alexandria, Virginia. Although the report focused on pure devices, he concedes that “we don’t think it would be inappropriate if the FDA stepped back and looked at the whole panoply of products it regulates.”

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