Writing a Pre-Submission to the FDA

[gowdardivya]

Dear Community -
I am in the process of writing a presub and I would like to see if anyone can share a redacted copy of the presub so that I can get an idea on format and contents. I did review the FDA guidance document for general format and have an idea. But it will be great to see an example! Thanks so much!

 

[vinothkumarp]

Hello Chris,

It's interesting. Could you please share any redacted copy for our understanding and to learn?

Thanks.

Hi

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

Chris

 

[chris1price]

Please read this thread in its entirety, and my previous responses.