NCPA - National Center for Policy Analysis

Stifling Medical Device Innovation

October 11, 2011

The United States has long been the home to cutting-edge innovations in the medical device industry.  However, increasingly burdensome regulatory policy is driving pioneering research and development to Europe and the rest of the world.  Nevertheless, the U.S. Food and Drug Administration (FDA) and self-styled public health advocates are engaged in an assault on the primary regulatory pathway through which new products reach the market.  This could lead to further erosion of U.S. leadership in this important field, says Larry R. Pilot, an attorney and pharmacist.

The primary law governing medical devices, enacted in 1976, established a flexible review process intended to tailor FDA oversight of new and improved devices to a level of regulatory control sufficient to provide a reasonable assurance of safety and effectiveness.

  • Most new devices incorporate fairly modest changes or improvements on previously marketed ones.
  • For that reason, an estimated 90 percent or more of the devices now on the market have been authorized for commercial sales through what is known as the 510(k) process.
  • Theseproducts do not go through a full premarket approval, but they are nevertheless subject to numerous and burdensome legal requirements to ensure their safety and effectiveness.

The FDA recently proposed additional changes that would make the 510(k) review even more onerous, and a report from the Institute of Medicine has called for scrapping the 510(k) process altogether.  However, most criticisms of the 510(k) process are based on a misunderstanding of how it works and why it was designed the way it was.

Arguably the most stinging safety criticism that can be made against the FDA is not that the 510(k) clearance process is flawed per se, but that the agency has mismanaged it by occasionally clearing devices that were not in fact substantially equivalent to predicate devices.

Rather than scrapping the entire process, a more effective approach to protecting consumers and promoting innovation is for Congress to engage in more vigorous oversight and investigation of the FDA's performance.

Source: Larry R. Pilot., "Stifling Medical Device Innovation: A Response to Critics of the FDA's 501(k) Clearance Process," Competitive Enterprise Institute, October 2011.

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