If you're a startup or small company looking to bring a new device to market, dealing with the FDA can be overwhelming. The list of questions can seem endless - What product code do I need? What's the best submission pathway for my device? Where can I find information about predicate devices? What is ISO 10993 and why does it matter to my device?

Listen in as Michelle explains all this and more, clarifying the various processes and laying a foundation for your interactions with FDA.



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