Device Labeling "Manufactured for"

O

oskameyer

#1
Can someone share some regulatory expertise on this? I am the 510k owner of a medical device for the US market and have contracted out the manufacturing of the device. Technically, I fit in the "manufacturer" definition of FDA (21 CFR 820.3) because I own the design but since I do not physically manufacture the product at my facility, must I have "Manufactured for" with the name of my company and address on my product labeling? I am having a problem interpreting the intent of 21 CFR 801.1(c), which states "where a device is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such device, such as, 'Manufactured for ___', 'Distributed by ___', or any other wording that expresses the facts."

I assume this clause pertains to private label manufacturers and not to manufacturers who are outsourcing part or all of the manufacturing/packaging activities. Am I correct?

Thanks,
Oscar
 
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M

MIREGMGR

#2
One of the purposes of medical device labeling is to allow the user to identify the marketer (in FDA parlance, the Manufacturer), who is legally responsible for the device's regulatory compliance.

When the current rules were created, as a political compromise with distributors, private labeled devices were not required to be identified with the name of the Manufacturer...but to make clear that the distributor is not the Manufacturer, the labeling must state "Manufactured For" or "Distributed By". A user thus is made aware that in order to learn who is regulatorily responsible for the product, they must ask the distributor or otherwise research the matter.

You are the marketer of your own product, thus your label should merely state your name. It does not need any further language to characterize who did what.

The fact that you engage a contract manufacturer to make some or all of the product for you is regulatorily irrelevant.
 

Wes Bucey

Quite Involved in Discussions
#3
<SNIP>

The fact that you engage a contract manufacturer to make some or all of the product for you is regulatorily irrelevant.
I agree with this. In context, it is not dfferent than using some other manufacturer's off-the-shelf fasteners to hold your product together. If you hold the 510k, you are responsible for the final assembly which reaches the user (as far as FDA as concerned.) That is not to say that (in the event of a negative experience by a user) a smart lawyer won't look all up and down the supply chain for deep pockets, regardless of FDA consideration of responsibility.
 
M

melvin345

#4
What if you do not own the design? How is the label supposed to be for those circumstances?
 
M

MIREGMGR

#5
"Own the design" is commonly used wording, but doesn't have a uniform meaning from a regulatory perspective. "Own the design", for instance, can refer to the owner of underlying intellectual property, which is licensed to a company that Manufactures a device, which they had contract designed, have contract manufactured, and sell through third parties.

Who is the Manufacturer of the product...who's regulatorily responsible for it? If there was a 510(k), who was the applicant? If there's a CE Mark, whose?
 
M

melvin345

#6
We own the product's design as the manufacturer and we have a 510k on product. It also has a CE marking. They are buying the product fromus in bulk and labeling the product as their own. They are selling in the states and are not placing the CE mark on the label. Should they use ours or theirs if they do sell in the EU?
 
M

MIREGMGR

#7
This is getting complicated. Maybe you need a consultant to occasionally advise you on such matters.

Should they use ours or theirs if they do sell in the EU?
That depends on (among other things) who they and you want to be legally responsible for the product in that market.
 
M

melvin345

#8
So is the company that is private labeling our product supposed to put our name on the label or only identify themselves as the distributor?
 
M

MIREGMGR

#9
That depends on what they're doing with it, how they're registered, and whether they're trying to do a combined US/Canada/Europe label or just US.

If they don't understand these issues well enough to explain them to you with regulatory citations to back up their statements, then they need a better regulatory person.
 
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