High risk medical devices lack U.S. FDA scrutiny, GAO says

April 12, 2011, 9: 03 pm EDT by Catherine Larkin and David Voreacos

(Updates with number of callbacks to the seventh paragraph).

April 12 (Bloomberg) - high risk medical devices are allowed on the market without proof of security by U.S. regulators doing poor withdrawals of follow-up work when problems arise in marketingthe Government Accountability Office found.The Food and Drug Administration has given reviews accelerated to at least 67 devices such as pacemakers and the hip joints since the GAO called in January 2009 for the "immediate measures" to tighten standards for approval or reclassify the potential risks, according to the testimony of Marcia Crosse, Director of GAO's health care. The Senate Special aging Committee is scheduled to discuss the findings at a hearing tomorrow in the series Washington.A of withdrawals from device led by Johnson & Johnson decision year last to get legislators to market stimulated to consider approval of the 93,000 artificial hips agency processes. FDA has been slow to implement a 1976 Act requiring that all the devices high-risk undergo strict control. Many are still identified with minimum testing program of so-called 510 (k) if companies prove they are similar to existing products, said the GAO, the arm of inquiry of the Congress. "Concerns persist about the effectiveness of the process of 510 (k) in General, including its ability to provide sufficient assurance that the devices are safe and effective,"butts said in testimony written for the hearing of the future. ' Critical ' 510 (k) program ProgramThe, which erases about 3 800 to 4 000 products per year, is "critical to a successful and dynamic device industry," according to the testimony of David Nexon hearing, Executive Vice President of advanced medical technology Associationa trade group. He said the process "has a copy", to protect the public against dangerous devices.The FDA conducts an internal audit of the 510 (k) and requested the opinion of the Institute of Medicine, an independent arm of the National Academy of Sciences. The Agency in January announced 25 measures to improve the consistency and transparency in the review process. Several changes were returned to the Institute, which plans to publish a report of this year.Eighty-one percent of the devices removed 113 deemed of withdrawals at high risk by the FDA from 2005 to 2009 have been approved under the less stringent route 510 (k), researchers, said February 14 in the journal Archives of Internal Medicine.

-With the help of Alex Nussbaum in New York and Molly Peterson in Washington. Editors: Andrew Pollack, Peter Blumberg

To contact the reporters on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net. David Voreacos in Newark, New Jersey, the dvoreacos@bloomberg.net

To contact the responsible editors of this story: Reg Gale to rgale5@bloomberg.net; Michael Hytha to the mhytha@bloomberg.net

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