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Institute of Medicine calls for medical device regulation reform

Posted on August 3rd, 2011 No Comments

Last Friday, the Institute of Medicine announced that they believe that medical device regulation in the U.S. needs complete reform.  The current system for regulating medical devices like hip replacements, pacemakers, and contact lenses has been used for 35 years.

The Food and Drug Administration and device manufactures expressed disagreement with the Institute’s review of the current medical device regulation system.  The FDA commissioned the review from the 12-member medical board.

Currently, the majority of prescription medications are required to go through clinical trials and prove that patients are benefited by a drug before they enter the market.  However, most medical devices are simply required to prove that they are similar to a previously approved device.

If you or someone you know was negatively affected by a recalled DePuy hip replacement, contact the DePuy hip recall attorneys of Williams Kherkher at 800-761-3187 to discuss your case with an experienced product liability lawyer.

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