FDA may drop medical device 'fast track' amid overuse concerns

The Food and Drug Administration may eliminate a program that allows medical devices to be approved quickly because of concerns the program is overused, The Wall Street Journal reports. An internal FDA memo proposes the elimination or tightening of the "fast track" as officials question the use of private, third-party companies "hired by device makers to pre-review products. If the third party signs off on the device, the FDA may approve it without much further scrutiny." The Journal quotes the memo as noting the "Real value to industry may be that this is perceived as a way to 'sneak things in.' … The industry will have a chance to air its views at a public meeting Thursday." The FDA started examining how devices are approved after a Journal story about a knee implant and how it was approved for use using a method that allows "fast track" approval for devices similar to earlier devices (Mundy and Favole, 2/18).

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This article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.