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FDA Medical Device Approval Process Questioned

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According to ABC News, a panel of medical experts has said the Food and Drug Administration’s streamlined review process called 510(K) should be abandoned because it fails to offer patients safety assurance.

Instead of the 510(K) process, the Institute of Medicine said in a recently released report that the FDA should require each device maker to prove moderate-risk or Class 2 products are safe and effective, and test products on actual patients, because “The 510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk Class II devices and cannot be transformed into one.”

The Government Accountability office said last week that nearly 83 percent of 700 Class 2 products are recalled each year.

The FDA says it stands behind the controversial 510(K) approval process because it has helped foster a “robust medical device industry in the U.S. and has helped bring lower-risk devices to the market for patients who need them.” The agency has said however that it will have a public meeting regarding the institute recommendation.

A list of all medical devices recalled since 2001 and information regarding what to do if you own or use a recalled product can be found online at http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/default.htm .

 

breakinglawsuitnews.com disclaimer: This article: FDA Medical Device Approval Process Questioned was posted on Monday, August 1st, 2011 at 6:53 pm at breakinglawsuitnews.com and is filed under Medical Device Lawsuits.

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