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X • 1 Wall St. Journal New Y3rk, VY • +f!1C ~ ~ ~r^, Li f esaving Devices Languish at the FDA Your Feb. 10 editorial "Kessler's De- vices" on the bottleneck in FDA approval of new medical devices has broug'fit to light an enormous problem. As a practicing cardiologist, I believe that the American public needs to understand in detail the enormous magnitude of the problem these bureaucratic delays have caused. Under Dr. David Kessler's manage- ment, the Food and Drug Administration has become paralyzed with respect to the approval or disapproval of new devices. Currently, development of medical devices is at a standstill. It's a tragedy that people are unable to obtain many lifesaving de- vices that are widely available in Europe, South America and Japan. As a result of bureaucratic mismanage- ment, lengthy delays and lack of clear guidelines from the FDA, no new cardiol- ogy devices have been approved during the past year. In spite of the fact that a physician's advisory panel has strongly recommended approval of the Interven- tional Technology atherectomy device, the Cook intracoronary stent and the Heart Technology rotablator, these devices are still nowhere near approval. Many pa- tients are being harmed because we are unable to treat them with devices that can be potentially lifesaving. Many medical device companies are now going overseas to develop new and better devices. President Clinton says he wants to improve health care in America and create good new jobs. His administration can greatly aid the American medical device industry and provide better access to life- saving medical devices by insisting on more rapid device evaluation and approval by the FDA. WtLLtAm W. 0'NEtt.t., M.D. Director Division of Cardiology William Beaumont Hospital Royal Oak, Mich. ~ O I~. CT~ ~ ~ ~~