FDA’s Refusal to Test High-Risk Medical Devices

December 4, 2013 | Crandall & Pera Law
FDA’s Refusal to Test High-Risk Medical Devices

Many high-risk devices that are widely used in the medical community have never been subjected to the rigorous premarket approval process the Food and Drug Administration routinely requires for new drugs, according to The New York Times.

Researchers fear that nearly a dozen medical devices, including external cardiac compressors, may never be thoroughly evaluated by the agency because they are presumed to be roughly equivalent to products already in use before the FDA began regulating devices in 1976.

These high-risk devices, meaning they sustain human life or pose an unreasonable risk to patients, include external pacemakers, access tubes implanted in blood vessels, a component of a lung device used for newborns, dental devices that are implanted near the brain, and screw systems used in spinal surgery. The FDA proposes downgrading the classification of these products so they are no longer considered high-risk instead of putting them through premarket approval.

"People would be shocked to know that the FDA never got its act together to require the studies," said Diana Zuckerman, president of the National Research Center for Women and Families. Other devices, including defribrillators and implanted pacemakers, will remain high-risk and must undergo premarket approval. Read the full details here:

New Scrutiny for Medical Devices

Everybody wants to get potential life-saving products on the market as soon as possible.  This desire, however, must be balanced by rigorous testing. Products that may seem perfect, often times are not.

If you have been injured due to medical malpractice, including faulty medical devices, please call to investigate your matter fully. Crandall & Pera Law is available to help answer your questions and guide you in determining your next steps.