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Washington, D.C., October 12, 2011—The Food and Drug Administration’s 510(k) review process for medical devices has been severely mismanaged by agency officials, according to a new study  published today by the Competitive Enterprise Institute . The FDA has added comprehensive new data and testing requirements that do not enhance patient safety, but the growing lack of transparency and predictability in the review process is leading to an exodus of pioneering research and development from the United States.
The 510(k) process has recently been criticized by some public health experts because it provides for an abbreviated FDA review of relatively simple medical devices that are substantially equivalent to others already on the market. FDA’s comprehensive premarket approval process applies only to entirely novel products and Class III devices, those used in supporting or sustaining the life or health of patients. But, as the new CEI study notes, less sophisticated Class I and II devices are still subject to numerous and burdensome regulatory standards and manufacturing safeguards. “The 510(k) process was never intended to provide a comprehensive safety or effectiveness review because the regulatory controls associated with the device classification system are sufficient to provide a reasonable assurance of safety and effectiveness,” said study author Larry R. Pilot, a former FDA official who helped establish the classification and review system for medical devices.
Over the past year, the FDA has proposed adding new hurdles to the 510(k) review process, and a July 2011 report by the Institute of Medicine called for eliminating it altogether and subjecting all new devices to a comprehensive premarket review. However, in Stifling Medical Device Innovation: A Response to Critics of the FDA’s 510(k) Clearance Process , Mr. Pilot explains that the 510(k) process provides substantial benefits for patients because it tailors FDA oversight to the complexity and sophistication of individual devices and keeps the medical device industry nimble and innovative. “Without the 510(k) process, simple products could be subject to redundant and unnecessary testing,” said Pilot. “That would do nothing but raise the cost and delay the introduction of improved medical devices with no foreseeable benefit to the patient or clinician.”
The study also documents the increasing regulatory burdens that Congress and the FDA have heaped onto the 510(k) clearance process during the past two decades. “It has become so demanding that most observers now see little difference between the 510(k) process and full premarket approval,” said CEI Senior Fellow Gregory Conko . “This study explodes the myth that 510(k) clearance is too lax, and it makes clear just how onerous the process truly is.”
► Read the full study, Stifling Medical Innovation: A Response to Critics of the FDA’s 510(k) Clearance Process, here.