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.

We are passionate about your success. Tell us more about your needs so we can help.

Book a Consultation


To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.

Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!