Speeding up Medical Device Review and possible Quality Impact

A Wall Street Journal article (15 February 2011) describes a study of medical devices that received quick approval – if the device to be similar to others in the market and is intended for low to moderate risk patients.  The study found that of the devices that failed in use, 70 % of the devices had received quick approval.  The associated question is whether the speeded up approval process (which decreases approval fees from $ 800,000 to $ 20,000) potentially creates failure risks.  In other words, is there a basic review time that cannot be decreased except for a drop in quality of approvals ? Given the current (early 2011) US administration’s focus on decreasing regulations, s there a danger of increasing risk ? Could the quality issues that showed up during use have been eliminated with a more thorough review, with consequent higher costs and lead times, and thus higher customer prices ?

About aviyer2010

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