Writing a Pre-Submission to the FDA

V

venezia

#11
@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 :(

Cheers!
jb
Hi JB,

The information he sent is rather useless. He is just trying to get business from you.

fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm311176.pdf

This guidance is really useful. The template that I have received from our own consultant follow this.
 
J

jiamgmt

#12
Thank you @venezia!

I was using the same FDA guidance so I appreciate the confirmation. I was also able to do some digging and find a couple of examples of pre-submissions other companies have made available online--none of them terribly useful. There are some helpful opinion and scholarly articles also available but finding a well-prepared example of a pre-submission doesn't seem to be available anywhere.

The other method I've used to inform my pre-submission process is referencing decision summaries from the FDA on 510(k) I'll ultimately have to write.

Best of luck!
Jb
 
V

venezia

#13
Thank you @venezia!

I was using the same FDA guidance so I appreciate the confirmation. I was also able to do some digging and find a couple of examples of pre-submissions other companies have made available online--none of them terribly useful. There are some helpful opinion and scholarly articles also available but finding a well-prepared example of a pre-submission doesn't seem to be available anywhere.

The other method I've used to inform my pre-submission process is referencing decision summaries from the FDA on 510(k) I'll ultimately have to write.

Best of luck!
Jb
It is because pre-submission contains confidential information of the company. It is very rare that a well-prepared example will be made available online. Even a template from the top consultant will only provide title section and some explanations that you will be able to find from the guidance document.

Please keep in mind that any pre-sub feedback from the FDA is non-binding.
 
J

jiamgmt

#14
It is because pre-submission contains confidential information of the company. It is very rare that a well-prepared example will be made available online. Even a template from the top consultant will only provide title section and some explanations that you will be able to find from the guidance document.

Please keep in mind that any pre-sub feedback from the FDA is non-binding.
Yes, I've been speaking with some of the FDA staff members and they have been very helpful but consistently remind me that while the pre-sub feedback probably will not change in the 510(k) pre-market notification, it is non-binding.

Do yo have any other recommendations or best practices for the pre-sub process--aside from just hiring a consultant (which is actually how I'm leaning at this point).
 
#15
The format of a pre-submission depends on what are you doing it for. A pre-submission can be done for 510k, IDE, etc. Please follow FDA guidance on pre-submission, they have very clearly defined what elements should be included in the submission. It is important to include a Q sub-RTA checklist, and just like for all other submissions, an e-copy and paper copy needs to be submitted to the FDA - the number of copies to be submitted can be located in FDA e-copy guidance. All the best!
 

Dobby1979

Starting to get Involved
#17
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
Hi Chris.

A little while ago now but I was wondering if you still had a redacted copy copy that I could take a look at. Just looking to0 plan a pre-sub as we speak.

Thanks
 

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