The Institute of Medicine (IOM) has issued a report titled “Medical Devices and the Public’s Health, The FDA 510(k) Clearance Process at 35 Years,” calling for an overhaul of Food and Drug Administration (FDA) procedures for approving medical devices that are considered a moderate risk to patients and are substantially equivalent to any previously cleared device or one that was on the market before the Medical Device Amendments were enacted in 1976. According to IOM, “Devices that were on the market before the Medical Device Amendments were never systematically assessed for safety and effectiveness—but they are being used as predicate devices.” IOM also found that FDA’s postmarketing surveillance of devices is insufficient.  

Responding to concerns that the 510(k) premarket approval process for clearing medical devices may not ensure their safety and effectiveness and that the process has become cumbersome and time-consuming, IOM recommends that Congress change the medical-device regulatory framework. Specifically, IOM calls for the development of “an integrated premarket and post-market regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle.” The framework would be (i) “based on sound science,” (ii) “clear, predictable, straightforward, and fair,” (iii) “self-sustaining and self-improving,” and (iv) “risk based.” The framework, according to IOM, would also “facilitate innovation . . . by making medical devices available in a timely manner.”

Meanwhile, FDA has issued a request for comments on the report. Noting that the agency had requested the IOM review and report, FDA indicated that the agency had not yet fully evaluated it but recognized “the strong public interest in the comprehensive assessment of the 510(k) process and the IOM report.” Comments must be submitted by September 30, 2011. According to an agency spokesperson, “FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs.” See FDA News Release, July 29, 2011; Federal Register, August 1, 2011.