Med-tech industry to FDA: IOM’s 510(k) report falls way short

The Institute of Medicine’s report on the FDA’s 510(k) clearance process for medical devices falls so far out of the scope of the questions it was meant to answer that it’s essentially meaningless, med-tech industry reps told the agency during negotiations over re-authorizing the Medical Device User Fee & Modernization Act.

Representatives from Boston Scientific (NYSE:BSX), Quest Diagnostics (NYSE:DGX), Laboratory Corp. (NYSE:LH), the Advanced Medical Technology Assn., the Medical Device Manufacturers Assn., the Medical Imaging & Technology Alliance met with the federal watchdog agency August 9 to negotiate the structure of the new MDUFMA. Minutes from the meeting reveal that the med-tech industry takes a dim view of the IOM report, which was nearly 2 years and $1.3 million in the making.

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