Conservative think tank report blasts FDA

October 12, 2011 by MassDevice staff

The Competitive Enterprise Institute, a conservative think tank, blasts the FDA and patient safety advocates for smothering new medical technology and calls for stricter oversight of the federal watchdog agency.

Competitive Enterprise Institute

A conservative think tank is taking aim at the FDA's program for reviewing medical devices, accusing the federal watchdog agency and public safety advocates of smothering new medical technology.

The Competitive Enterprise Institute report, "Stifling Medical Device Innovation: A Response to Critics of the FDA's 510(k) Clearance Process," was written by Larry Pilot, a lawyer and pharmacist who helped pioneer the FDA's Office of Medical Devices in the late 1960s and early '70s.

Pilot calls for stricter oversight of the FDA and its Center for Devices & Radiological Health, arguing that critics of the 510(k) program don't understand its purpose. Furthermore, he writes, the FDA is too liberal in exercising its authority to require clinical trials.

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"[T]he 510(k) review was designed to ensure that new products were assigned to the correct class. It was not intended to establish an independent safety or efficacy review process akin to premarket approval because the regulatory controls associated with the classification system itself are sufficient to provide a reasonable assurance of safety and effectiveness," Pilot writes (PDF). "During the past 20 years, the FDA has become more aggressive in using this authority, and it has required more and more devices to go through the full PMA process. This has drawn out both 510(k) and PMA review times and has created an atmosphere of unpredictability and uncertainty about what will be necessary to get products to market. Yet, critics have increasingly called for even more legislative and regulatory burdens."

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