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FDA Meets To Discuss Device Approval

Posted By Regan Zambri & Long || 28-Apr-2009

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

The New York Times reported recently that the Food and Drug Administration (FDA) will conduct a rare meeting to discuss its device division, which is responsible for, among other things, evaluating, monitoring, and regulating medical devices.  According to the report, Dr. Donna-Bea Tillman, the agency’s director of device evaluation, called an "all-hands" meeting.  This comes in response to a letter from nine scientists who have written President Obama, charging that some in the agency have acted illegally, exposing the public to harmful, even deadly, products.  

In the letter to President Obama, the scientists claimed that the device center inappropriately approved imaging studies designed to detect breast cancer and also allowed hospitals to wash and reuse device that were designed as single-use products, among other things.  Congress instituted an investigation into the charges. In January, the Government Accountability Office released a report that criticized the device center.

To read the entire Times article, please click here.

We hope that the FDA will seriously evaluate its deficiencies and make the changes that are necessary to protect the public from dangerous devices.

For information about defective devices and your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-759-6699.

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