510(k) Statement Requests to a Company

[rwend07]

Hey all,

I am in the middle of trying to collect data on predicates for a 510(k) submission. As I have read searching through the forum, FOIA requests are generally too slow to be effective (I probably will request one anyway, but expect it not to be useful). With that said, the predicate 510(k) we have chosen provided a 510(k) statement and not a summary, so as I understand it we can request data from them directly. I have a couple of questions about this request:

1. What is the appropriate way to do this? Is there any guidance for submitting a 510(k) statement request to the company? Any specific wording we should make sure we add to it?

2. Who do you contact? Do you contact the person listed in the 510(k) or do you try to search out an appropriate contact within the company?

3. What are the chances of getting anything useful out of this request? Do companies generally try to argue everything is trade secret and nothing can be disclosed?

I tried searching all of these answers but a lot of the posts got sidetracked before they got into this level of information.

Thanks for any help!

 

[Ronen E]

Hello rwend07 and welcome to the Cove

I certify that, in my capacity as (the position held in company by person required to submit the premarket notification, preferably the official correspondent) of (company name), I will make available all information included in this premarket notification on safety and effectiveness within 30 days of request by any person if the device described in the premarket notification submission is determined to be substantially equivalent. The information I agree to make available will be a duplicate of the premarket notification submission, including any adverse safety and effectiveness information, but excluding all patient identifiers, and trade secret and confidential commercial information, as defined in 21 CFR 20.61.

A1: I'm not aware of any FDA guidance on how to make such a request. I would word the request letter based on the 510(k) statement mandatory text (see above).

A2: Look up the predicate's listing in the FDA's database and note the Official Correspondent's name and address.

A3: I don't have any direct experience with such a request, but I assume that the information you can get should be at least similar to what you'd normally find in a 510(k) summary. Otherwise it would be a giant loophole. I also think that if you don't get anything useful you could get the FDA involved.

Cheers,
Ronen.

 

[mihzago]

As Ronen sugested, contact the official correspondent. If that doesn't work, contact someone at the FOIA office.
I would also suggest you have an unaffiliated consultant request the info on your behalf.

The company is allowed to redact the information, to protect their trade secrets and confidential information, and I've seen different companies take it to different levels.
I once requested one and received effectively about 300 hundred pages of blank ink.
The company redacted everything except for the 510(k) summary and some of the standard forms, e.g. Truthful and accuracy statement, intended use statement. Even the Instructions for Use were redacted.
Hopefully your request will have more useful info.

 

[NicoleinFlorida]

Hello,

Do you mean you have to submit a summary instead of a statement? In my case, I always try to make my statement or summary very similar with the predicate. If they use a statement, I will create a statement based on theirs and make modifications for our device. And if they use a summary, I will use the summary. It will be much easier for you and the FDA reviewer to compare those documents side by side.

Hope it will help.

 

[Ronen E]

Hello,

Do you mean you have to submit a summary instead of a statement? In my case, I always try to make my statement or summary very similar with the predicate. If they use a statement, I will create a statement based on theirs and make modifications for our device. And if they use a summary, I will use the summary. It will be much easier for you and the FDA reviewer to compare those documents side by side.

Hope it will help.

The statement is not something that's supposed to be customised. There is a standard wording that you're supposed to follow (see my previous post above). Plus, the FDA examiner working on your 510(k) submission doesn't need the predicate's 510(k) summary or statement, because they have the entire predicate's 510(k) submission in front of them. I believe that this is what they use for determining substantial equivalence.

The summary is mainly intended for the general public, including companies looking for appropriate predicates. The statement is, in my view, just a way around submitting a summary (perhaps to reduce information visibility, perhaps to save some work), and in essence it's effect is to allow interested parties to still obtain the information that would have been available to them if a summary was submitted (hopefully in a more timely manner than through a FOIA request).

Duplicating the predicate's summary format (and maybe some of its contents) is an easy way and I have seen it done in the past, however it is not something that is required or implied as necessary, as far as I know.

 

[rwend07]

Thank you everyone for your help. Will definitely take everything into consideration.

 

[kmbird33]

I am looking at this from the other side. I provided a 510k summary not a statement with by premarket submission. My device received clearance and I have received a request from an individual for safety and effectiveness information included in our premarket notification. Do I need to supply anything other than the 510k summary that is already available on the FDA site?

 

[Ronen E]

I am looking at this from the other side. I provided a 510k summary not a statement with by premarket submission. My device received clearance and I have received a request from an individual for safety and effectiveness information included in our premarket notification. Do I need to supply anything other than the 510k summary that is already available on the FDA site?

No. You don't even have to supply the summary. Your submission obligations are towards the FDA, not towards the general public.

 

[TroutBrook]

I would have shared a link but not enough posts yet.

Try googling a company called FOI services. I've purchased 510(k)s through them before. They don't have everything but they have quite a bit.

 

[Ronen E]

Here it is: http://www.foiservices.com/