Thursday, November 25, 2010

More on the FDA Approval Process for Hip Implants

I have posted other information on this topic but I found the article written by Lacy Boggs very informative in raising questions about the process used by the FDA to approve this particular implant for market.

As noted previously in a former post, the 501(k) process was used to gain approval of the Depuy hip through the FDA. This process is kind of a fast track that enables companies who submit devises that are “substantially similar” to those already on the market, a sort of reprieve from extensive testing. In theory this makes sense however, the definition of “substantially similar” can be viewed by manufacturers in different ways.

Mr. Boggs points out:
• It is perhaps not surprising that only 10% of 510(k) applications are referred back for supporting human, clinical or animal testing.
• 90% of claims require no clinical testing whatsoever before being sold to patients
• Many people note that the 501(k) process amounts to an enormous loophole, through which many companies bring under-tested products to market. With better testing, the DePuy hip recall might have been avoided altogether.
• On August 4, 2010, the FDA issued two reports that recommend sweeping changes to the 510(k) process and procedures. We can only hope they include actually testing the products to which the FDA affixes its seal of approval.


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