Licensing of a 510K to another manufacturer

M

ManTheDan88

#1
Hey All,

I have a question concerning the licensing of an 510k to another manufacturer. Manufacturer A owns a 510k and is currently private labeling the 510k device to Manufacturer B. Manufacturer B decides it wants to manufacturer the device themselves under Manufacturer A?s 510k. Is it as simple as Manufacturer A granting Manufacturer B the right to manufacturer the device under their name through a signed agreement? Or would Manufacturer B need to file a new 510k to manufacturer the same device? I look forward to your guidance.

- D
 
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Michael Malis

Quite Involved in Discussions
#2
Re: Licensing of a 510K

Hey All,

... Manufacturer A owns a 510k and is currently private labeling the 510k device to Manufacturer B. Manufacturer B decides it wants to manufacturer the device themselves under Manufacturer A?s 510k. Is it as simple as Manufacturer A granting Manufacturer B the right to manufacturer the device under their name through a signed agreement? Or would Manufacturer B need to file a new 510k to manufacturer the same device? I look forward to your guidance.

- D
Manufacturer B need to have their 510(k)! A is private label for B, does not make B a manufacturer. B needs to prove to the agency that their Quality System and Processes are appropriate, so the FDA will provide a clearance for B to produce this product.

I hope this helps,
Michael
 
M

ManTheDan88

#3
Re: Licensing of a 510K

Even if manufacturer B is a FDA registered manufacturing facility and manufacturers a similar product?
 

Michael Malis

Quite Involved in Discussions
#4
Manufacturing "similar product" does not give you the right to manufacture this product. Again, you need to prove to the agency that you have a system and processes and it is up to the agency to decide...
 
M

MIREGMGR

#5
I don't quite agree with Michael above. The rules in several places say that the maker of a 510(k)-required device must have such a 510(k), and there is no provision in the DLRM website, for instance, for a Lister to explain that the 510(k) they identify by number as applying to their manufacturing activity for a particular Listing is not theirs but they have permission to solely reference it.

But FDA documents also have long discussed the transfer of a 510(k), such as by sale. If a 510(k) can be sold, it must also be able to be leased, i.e. licensed.

We know that FDA's 510(k) database identifies only the original submitter. FDA does not have a role in any subsequent transfers or other transactions, so if you do a Listing and cite a 510(K) that wasn't issued to you, you're volunteering for an inquiry from FDA asking for documentation that you have current ownership of, or exclusive permission to use that 510(k).

The current FDA guidance on 510(k) transfer and related issues is at http://www.fda.gov/downloads/medica...onandguidance/guidancedocuments/ucm427385.pdf.
 

Michael Malis

Quite Involved in Discussions
#6
But FDA documents also have long discussed the transfer of a 510(k), such as by sale. If a 510(k) can be sold, it must also be able to be leased, i.e. licensed.
].
In above correspondence there is no discussion about sale. Yes if A sold product to B, you can TRANSFER 510(k) with sale to the new owner. I am not aware of any other situation when licencing 510(k) is OK.
 
M

MIREGMGR

#7
I think the bottom line is that FDA's guidance regarding 510(k) transfer, or use by a party other than the original submitter, is inadequate. The range of potential scenarios is large, and FDA provides no help as to any of the subtleties.
 
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