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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

Involved In Discussions
#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
 

duinyk

Starting to get Involved
#18
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.
Was this for a 510K? Please do you still have this template? Thanks
 

Ronen E

Problem Solver
Staff member
Super Moderator
#19
If you read @venezia's post #11 above you'd have seen that @StevenJaeger wasn't helpful. Besides, as explained by some here, such templates won't progress you too much. On top of what's already been said, pre-subs are highly specific so even if you did get access I doubt that the benefit you could gain from one could justify the time you'll have to put into studying it and then heavily editing.

I can help you create a pre-sub along the FDA's guidance, but as people might call it here I would be "getting business out of you" (ew!...), so, sorry...
 

Watchcat

Quite Involved in Discussions
#20
duinyk,

I don't know if you consider yourself to be a regulatory professional (or if maybe your management has informed you that you are one). You may have considerable experience with the product registration process, which in some markets is not that much different than registering your car or business. FDA premarket review is not product registration.

When someone is in search of a template or an example or boilerplate for an FDA submission, I think this is not going to have a happy ending. If you feel a need more than the guidance that FDA provides, you would probably do well to seek the services of a consultant experienced with FDA submissions. (I fully appreciate that this is easy to say and not so easy to get management to agree to.)

If a consultant is trying to get business out of you, they may be doing you and your company a favor. Or not. Depends on how they do it and what they have to back it up with.
 
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