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FDA to change 510(k) process 25 ways

1/19/2011 10:50 PM EST
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selinz
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re: FDA to change 510(k) process 25 ways
selinz   1/20/2011 1:17:21 AM
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Well, if I'm interpreting this correctly, similar devices by presumably other companies require less qualification. DOesn't this mean the first company that creates a new technology will bear the burden of all of the initial qualification? Subsequent companies can make similar devices and not have to go through the same level of qualificaiton? It seems that could have the effect of stifling new, innovative products...

rick merritt
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re: FDA to change 510(k) process 25 ways
rick merritt   1/20/2011 3:24:29 PM
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@Selinz: The FDA has long had two parallel paths--PMA for new devices and 510(k) for devices similar to approved ones. Yes, PMA is longer and more rigorous. The goal is safety, but it no doubt impacts speed of innovation, too.

Warren3
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re: FDA to change 510(k) process 25 ways
Warren3   1/20/2011 5:33:51 PM
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The response I'm seeing on the web is well described by another's wrap-up as the industry being "cautiously optimistic". There are a lot of changes under review and there is some dissappointment that only a small portion of which is covered by these recent proposed changes. But, again, the indications are positive. On a different note, I found it interesting that in the Medtronic "complaint" piece on 1/11/2011 it is the CEO expressing his concerns, while in this article the "FDA improvements look promising" Medtronic statement is supplied by their chief regulatory officer. For now I'm choosing to consider this as Medtronic's way of saying "we're seeing changes that make us feel optimistic but there's much more that should be done."

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