Left to Their Own Devices

FDA death toll rises as regulatory delays increase

Every year, thousands of Americans die because the Food and Drug Administration denies them access to life-saving medical devices. And things aren't looking up. For all but the riskiest devices, manufacturers have to submit a "pre-market notification," which is supposed to be approved or disapproved within 90 days. At first, these were routinely approved, but that changed after 1990. Thanks to the Safe Medical Devices Act of 1990 and the Medical Devices Amendments of 1992, the FDA spends more time reviewing applications than ever before. And Commissioner David Kessler has been calling for increased "consumer protection" (i.e., regulatory power) ever since he was appointed in 1990. Now he wants "user fees" to increase Device Center staff–$3,200 for run-of-the-mill devices and up to $50,000 for riskier ones.