Writing a Pre-Submission to the FDA



Hi all,

Anyone have experience with writing a presubmission to FDA? Is there a template or format that I should be following?

Thank you in advance!!!!


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Re: Presubmission


The presubmission process can be used to get advice from FDA on a range of issues associated with 510(k), PMA, IDE, etc and to set up meetings or conference calls with them. The presub is typically used to gain feedback on testing or protocols. However FDA will not analyse any data or give a pass/fail to a result.

Use the appropriate format laid out in the guidance document. See the links below:


If used correctly, they can be very useful. In a previous IVD company, a presubmission was made early in the 510(k) process to ensure we were about to perform appropriate validation testing.



Hi Venezia, if you send me a private message I'll be able to provide you with a download link to a redacted version of my startup's pre-sub cover letter and table of contents. This forum is not allowing me to post the link in-line here.

Hopefully it will be helpful in giving you a clearer picture of what would be relevant to include in the document. When my company met with the FDA in an in-person meeting to discuss our pre-sub, the FDA commented that ours was one of the best pre-subs they had seen, in terms of thoroughness, etc. So it should be a good guide.

If you would like further help in fleshing out what the contents of the document should be, I would be happy to help on a more involved basis.


I came across your post and wondered if you were willing to share a redacted copy with me? I also work for a startup and am working on a pre-sub. I specifically want to focus on my biocompatibility tests and making sure FDA agrees with my 1) selected tests and endpoints. We don't have any time or money to waste. I am happy to read you were successful with the pre-sub approach. How long did it take to schedule your meeting? I am reading the guidance and did you submit/file an e copy with your hard copy similar to a 510(k)? Many thanks for your willingness to share. I hope to return the favor somewhere on this site:)


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Below is the table of contents we use for Pre-Subs.

1. Form 3514 CDRH Cover Sheet
2. Submitter Details
3. Device Description
4. Proposed Intended Use/Indications for Use
5. Previous Discussions or Submissions
6. Overview of Product Development
7. Proposed Predicate Device
8. Proposed Equivalence
9. Proposed Testing & Studies
10. Specific Questions - This is the key section, the better the questions, the better the answers!
11. Desired method for feedback

If you PM me, I'll send you a redacted copy of one of our pre-subs. This should give you an idea of the format and what to include.

FDA should give you assistance on whether the selected tests are appropriate, however they may not talk about specific endpoints. They will want to see all the results as part of the 510(k). However if you are creative in asking the questions, they can be very helpful.

Yes, use the eCopy to create the CD, and send it with a printed hardcopy to FDA. You should get an acknowledment from the post room in a couple of days saying its been accepted. The reviewer typically responds in 60-90 days. We always asked for written response, but you can ask for a conference call as well. Dont forget the 3514 CDHR Cover sheet :)



Involved In Discussions
Hello Venezia,

In my opinion, you need to follow the FDA guideline. This guideline describes the documents that you need to submit. For example, a Cover letter. This cover letter must be a formal presentation of your document package.

Secondly, you will need to validate the package with e-submitter. The Presubmission process has its own "refuse to accept (RTA)". Anyway, I have submitted two previous pre-submissions and I never had a problem to close the meeting.

I think this is all. I hope this information can help



Thank you all for sharing your experience. I have read through the guidance and see this is very similar to the 510(k) process. I will post follow up on my experience to keep the collaborative environment going:)

Ballroom Blitz

Hi I am new to the forum
I saw your post would you also be able to PM that redacted pre-sub to me as well, we actually have one for a PMA and I would love to see one that was already successful.
Thank you


Hello All,

I am also in the process of writing an FDA pre-submission and would very much like to see any redacted copies of other users' pre-submissions.

I attempted PM'ing users that had expressed willingness to share but am a new member and as such it seems I do not have the ability to PM.

Any feedback would be greatly appreciated


@StevenJaeger would you be willing to share these redacted copies with me as well? Unfortunately I am unable to PM you as I am a new user :(

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