Medical devices--balancing regulation and innovation.

摘要

to the editor: The Perspective article by Curf-man and Redberg (Sept. 15 issue) is much too optimistic, as is the Institute of Medicine (IOM) report2 on which it is based. Both fail to acknowledge that the 510(k) process that the Food and Drug Administration (FDA) uses for approving ("clearing") new medical devices for marketing, though seriously flawed, will probably remain in place for the foreseeable future.