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More Information on the Device Review Process

Letter in New York Times Criticizing Weaknesses in FDA Oversight of Medical Devices

October 28, 2008

Fast Track Treatments for Cancer

To the Editor:

Your article highlights a fast-track system whereby the Food and Drug Administration clears most medical devices simply by declaring them equivalent to existing devices, rather than by direct proof of their effectiveness. In fact, the MammoSite system, a Class II device, is not the most egregious example of this phenomenon.

There are a number of more complex, typically higher-risk Class III devices (including some heart bypass machines and pacemakers) that have gained F.D.A. clearance through the same fast-track process detailed in the article.

This practice violates a statutory deadline requiring the F.D.A. to phase out the fast-track approval process for these highest-risk devices by the end of 1995. In the meantime, the companies producing these products continue to avail themselves of the fast-track system, at potentially great risk to public health.

Jonas Hines
Research Associate
Health Research Group at Public Citizen

Eunice Yu
Research Associate
Health Research Group at Public Citizen

Peter Lurie, M.D., M.P.H.
Deputy Director
Health Research Group at Public Citizen

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