The IOM's report on reforming the 510(k) system is out, and many industry insiders are speaking against it. And despite the vociferous uproar, Drs. Gregory Curfman and Rita Redberg in the New England Journal of Medicine come to its defense. "Despite its reasonable (and relatively modest) recommendations, the report has been aggressively attacked by the device industry and by politicians from states where device companies are located. In fact, the attacks began even before the report was released, which is highly unusual for an IOM report," the authors, who call the report "insightful, judicious, sensible and long overdue," write. Perspective