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FDA’s 510(k) gets tougher, more predictable

3/29/2012 04:39 AM EDT
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goafrit
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re: FDA’s 510(k) gets tougher, more predictable
goafrit   3/29/2012 12:58:03 PM
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FDA is the last line of defense as medical device innovation expands. They need to innovate in the approval process also.

docdivakar
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re: FDA’s 510(k) gets tougher, more predictable
docdivakar   3/30/2012 3:48:36 AM
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Scrapping the 510(k) completely is a bad idea, but some new approach to speeding the process is certainly needed. It seems to me that there are many commonalities here with those of the USPTO where approvals seem to bog down the entire system. Both are seeing increase in number of applications while the internal resources are dwindling in today's challenging economy. MP Divakar

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