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Rottenstein Law Group Commends Institute of Medicine Initiative to Persuade FDA to Rethink Evaluation System of High-Risk Medical Devices


(New York, NY, August 8, 2011) The Rottenstein Law Group, which represents clients with claims stemming from the severe side effects of various prescription drugs and defective medical devices, applauds the efforts of the Institute of Medicine to persuade the U.S. Food and Drug Administration (FDA) to re-evaluate and overhaul its practices for evaluating and approving many high-risk medical devices, allowing them to be sold to the public.

According to the Los Angeles Times, the Institute of Medicine, a division of the National Academy of Sciences, is “call[ing] on the government to design a new system for evaluating and approving many high-risk medical devices before they reach the market.”

Medical devices, the Times explains, “range from simple adhesive strip bandages used for minor cuts to contact lenses and pacemakers. When complex devices fail, they can generate health problems and healthcare costs, even imperil lives.”

“When the [FDA] was given responsibility for medical devices in 1976, Congress specified that those already on the market could continue to be sold without testing. At the same time, Congress created the so-called 510(k) process under which new devices could be cleared for market if they were ‘substantially equivalent’ to existing products. As a result, thousands of medical devices have received FDA clearance based on older devices, neither of which were subjected to the kinds of rigorous pre-market testing required for pharmaceuticals. Further, a study of high-risk recalls from 2005 to 2009 found that more than two-thirds of medical devices recalled for potentially serious risks went through the expedited approval process”, according to the article.

“In 2009”, the Times piece continues, “the Institute of Medicine noted, about 4,000 medical devices were cleared under the expedited 510(k) process; more than 90 percent of all devices subject to FDA clearance. Simple ‘devices’ such as tongue depressors and adhesive strips can be sold without FDA clearance, although companies must notify the agency. Critics contend that the 510(k) process amounts to a loophole for marketing products without adequate attention to safety or effectiveness.”
The Rottenstein Law Group maintains a Web site to provide pertinent information to the public about the dangers of specific drugs and defective medical devices. Those who wish to learn more will be able to find relevant information by visiting the site, which is updated regularly as new information becomes available.

About the Rottenstein Law Group
The Rottenstein Law Group is a New York-based law firm that represents clients in mass tort actions. The firm was founded by Rochelle Rottenstein, a lawyer with over two decades of experience in compassionate representation of clients in consumer product injury, mass tort, and class action law suits. For more information, please visit their Web site, or call (888) 9-ROT-LAW.


 personal injury
 consumer safety
 products liability
 defective medical product

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