Recommended Location for a 510(k) RTA Checklist with a 510(k) eCOPY


Involved In Discussions
What is the recommended location for including the RTA Checklist with a 510(k) eCOPY? If I add it to the beginning of our main submission pdf, it will make the numbering system be off (will add additional pages before the main submission/ToC). Would it be acceptable to have it within a separate file, perhaps within a MISC folder? I haven't seen any guidance on this and am not sure what the best option is.

510(k) Submission Process


Quite Involved in Discussions
As far as I know, FDA does not make any recommendations (or even require that an RTA checklist be included) so you're free to do as you wish.

I always do Volume-based submissions with 001 being an "Administrative" folder including the Cover Letter, Main Submission, Indications for Use and RTA checklist.

If you do a non-volume-based submission you could put the RTA checklist as an appendix to your Cover Letter so as not to interfere with the file numbering system.
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