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The world of in-vitro diagnostics is another Midwest success story

o get to the market place given the lower regulatory hurdles (and time) to achieve an FDA approval. A 510k approval means relatively little if any clinical trials, however with reimbursement a key issue for medical devices and diagnostics, a company is often faced with the question: do we "go" the more extensive PMA (pre-market approval) pathway with the FDA, or "go" with a quicker 501k developmen......

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Source:wistechnology.com By Michael Rosen 07/19/06


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