What are the common issues with 510(k) submissions that are easy to avoid?

Start with the device description because many times the questions coming back from FDA are basic misunderstandings. In the device description, go into way more detail and give it to someone that does not know the device so they can look at it and understand the device. In our FDA expert’s experience, the top three reasons for RTA1 are device description, incomplete test reports, and inconsistent data.

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