The Institute of Medicine (IOM) recommended that the Food and Drug Administration (FDA) dump the 510(k) process claiming the process is too flawed. The IOM stated the “FDA’s finite resources would be better invested in developing an integrated pre-market and post-market regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle.
Of course, the FDA does not agree. In addition, neither does the Advanced Medical Technology Association nor the Medical Imaging and Technology Alliance.
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