Requesting Information From FDA concerning Archived 510K

M

MLocke

#1
Can I request from the FDA information concerning another companies 510K; if so how? I know that this company in the past had a 510k on a specific product yet I can not find it on the website. I need to use it as a predicate device but can not find any information anywhere. What can I do?

Also can I purchase or somehow transfer a 510k from another company to mine...if that said company wishes to do so?
 
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Stijloor

Staff member
Super Moderator
#2
Can I request from the FDA information concerning another companies 510K; if so how? I know that this company in the past had a 510k on a specific product yet I can not find it on the website. I need to use it as a predicate device but can not find any information anywhere. What can I do?

Also can I purchase or somehow transfer a 510k from another company to mine...if that said company wishes to do so?
Can someone help?

Thank you!!

Stijloor.
 

bio_subbu

Super Moderator
#3
Can I request from the FDA information concerning another companies 510K; if so how? I know that this company in the past had a 510k on a specific product yet I can not find it on the website. I need to use it as a predicate device but can not find any information anywhere. What can I do?

Also can I purchase or somehow transfer a 510k from another company to mine...if that said company wishes to do so?
Hi Welcome to the cove!!!

Please refer the existing thread "Selecting a predicate device for FDA 510(k) approval" check especially post # 11 (page2) onwards...
 
M

MLocke

#4
I will proceed with the FOIA request, thank you; I thought so...Although, the second part of the question? Can a company choose to transfer a 510K to another company, I am assuming, yes...if that product and all the rights are sold to another company...but do you know where that process would start? Or should I seek some legal services?
 
M

MIREGMGR

#5
Can a company choose to transfer a 510K to another company, I am assuming, yes...if that product and all the rights are sold to another company...but do you know where that process would start? Or should I seek some legal services?
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm150086.htm#5k

See the last heading.

Practically, the FDA is notified of the transfer of a 510(k) when the new owner enters it into a device Listing at the DLRM website. Of course, any prior Listings in the name of the prior 510(k) owner must be discontinued prior to the new user creating such new listings.
 
J

JohnJohnson

#6
Can I request from the FDA information concerning another companies 510K; if so how? I know that this company in the past had a 510k on a specific product yet I can not find it on the website. I need to use it as a predicate device but can not find any information anywhere. What can I do?

Also can I purchase or somehow transfer a 510k from another company to mine...if that said company wishes to do so?
I just have found a series of videos you can rely to find a group to answer this specific question. They are reliable and experienced to give all the answers you need.

Hope this will help. :)
 
Last edited by a moderator:
D

Dudes

#8
Just a small remark (which doesn't necesarily apply to your case as it seems you have contacted the company that owns the 510(k)...

Be aware that if you do a FOIA request in your name, your competitor might be informed about it (he has the right to cross specific confidential infos before it is sent to you). If you don't want them to know you are up to something, it might be better to use a "middle-man" to do the request...
 
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