Revamping the 510(k) Process

Imagine your company recently developed an innovative medical device that draws upon well-established medical technologies and combines them in a new way to address a gap in the standard of care.  Your laboratory and animal testing demonstrates that your device performs as intended in all respects, and your confirmatory clinical data establishes a very good safety profile for your device - in fact, you believe that your device is actually safer than the standard of care.  In accordance with your company's business strategy, you obtained a CE mark to market your device in the European Union.  Management has now made it your job to file an application with the U.S. Food and Drug Administration (FDA) and get this product on the US market as quickly as possible.

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