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FDA Told to Toughen Medical Device Reviews

Jan 16, 2009 | Parker Waichman LLP, LLP The Food & Drug Administration (FDA) neglected to conduct appropriate medical device reviews, a new report by the Government Accountability Office (GAO) says.  According to Dow Jones, the GAO report involves some high-risk medical devices. This shocking news follows the revelation earlier this month that FDA scientists wrote to President-Elect Obama’s transition team looking to end corruption at the agency

The FDA is responsible for making sure that drugs, medical devices, and other products are safe to the American public.  It seems it has failed again and continues to put untold citizens who have been fitted or implanted with sensitive and high-risk medical devices in jeopardy.  The GAO’s report charges the FDA to immediately work to ensure high-risk medical devices be thoroughly reviewed as a opposed to it merely providing clearance, said Dow Jones.  Of note, external cardiac compressors are among the types of devices that do not receive thorough review.

In the letter written to John Podesta—Obama’s transition team head—the scientists noted that the FDA’s medical device area is of particular concern.  The group went on to explain that the medical device area has been "corrupted and distorted by current FDA managers, thereby placing the American people at risk," reported the Wall Street Journal (WSJ).  The letter also provided specifics on details such about how scientists who differed in opinion from management were threatened with disciplinary action.

The FDA defended its activities and how it is handling the allegations, but the scientists say no one has ever been held to task for the corruption and that the agency has gone so far as to reward and even promote some of the managers with whom they accuse of inappropriate practices, the WSJ said.  The controversial letter described an agency rife with corruption in which the scientific team basically begged for help and outlined a number of problems with an agency they describe as “fundamentally broken,” reported the WSJ.  Worse, it seems that this was not the first letter of its kind that the group sent out.  An earlier letter was sent to the House Energy and Commerce Committee this fall.

Meanwhile, the GAO report found that the FDA cleared 24 types of high-risk medical devices through a review process created for lower risk devices from 2003 through 2007 and wrote that it is  "imperative" the FDA act quickly to change the review process, pointing out that the agency has had over three decades to ensure such devices receive a complete review, said Dow Jones.  "They were even reminded about it again in 1990," said Marcia Crosse, director of the health care division at GAO.  "The combination of this report and last week's letter is a wake-up call to Congress and the incoming Obama administration: The FDA's Center for Devices is broken and needs a major overhaul," said Diana Zuckerman, president of the health advocacy group The National Research Center for Women & Families, said Dow Jones.

Federal law requires most high-risk—so-called Class III—medical devices undergo an extensive review process in which the device maker must prove the product’s safety and efficacy, said Dow Jones; proof typically involves clinical backup.  Less risky Class I and II devices—such as reading glasses and electrocardiographs, explained Dow Jones—are released to market when a company provides proof that the product is similar to others on the market and ostensibly approved.

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