Device Labeling "Manufactured for"

J

Jason PCSwitches

#11
[FONT=&quot]
Who actually manufactures the product????
Who certifies the product????

Liability falls on the organization that certifies the product, thus guaranteeing that the end results of usage will meet the outlined specifications.

Now I agree with Wes, a smart lawyer will only be interested in who has the money and how to get it. However another smart lawyer can demonstrate TRUE liability. Either way it's not cheap. But don't do more than you need to thus providing that smart lawyer an avenue to go after your $$.

This is a case where I would suggest consulting an attorney. It may be worth it in the long run. BTW, curious, what product are you having produced?[/FONT]
 
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M

melvin345

#12
We manufacture and certify the product that is sold to another company that does the private labeling for themselves. We make dental products that are medical devices. They do not have a regulatory department and tbey are asking us for advice. We label items for other companies that are distributors of our products and we include our name on the product as the manufacturer and define them as the distributor. This situation is a little different and there does not seem to be very clear regulations on how to deal with this.
 
J

Jason PCSwitches

#15
[FONT=&quot]Ok, unless I'm missing something (which my wife constantly reminds me) I think you should hold to the integrity of the standard to be safe; or get that lawyer. Which I happen to be but this isn't my bag.

[/FONT](c) 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.
 
M

melvin345

#16
Well that is what I first thought, but since this is a little different of a situation I was not sure if that is true.
 
J

Jason PCSwitches

#17
[FONT=&quot]Just take note that it is giving you a suggestion on how to demonstrate conformity. As long as you are meeting the intent of the spec, do it however you & your organization see sufficient and economical.[/FONT]
 
D

Deanb

#18
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.
MIREGMGR,

I've been hunting through the threads and looking at guidance documents and regulation on labeling for US Launch of a low risk device. Your comment was very helpful.

I have a quick clarification on the source of your information and a small clarification I'm hoping you can point me in the right direction for.

We're going to buy a Class I, PMA/510k exempt device from a company (Company A) who has designed it and private labels it for other companies (company B) in our field. (To be clear: Company A designs and manufacturers the device, includes Company B's name on the device, and Company B sells it). Ive suggested that we mark the device "Manufactured for COMPANY C", but our executives and marketing guys want it to say "COMPANY C" only for space and marketing reasons. Is it possible that I can compromise by marking the device "COMPANY C" on the actual device and including "Manufactured for COMPANY C" on the Device Label, which is on the box, and on the cover of the IFU?

In re-reading 21CFR Part 801, the statement "Manufactured for COMPANY C" is only required to be on the Label. When I went to verify that the term "Label" refers only to the information on the immediate container of the device, the FDA's Device Labeling Guidance #G91-1 (fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm081368.htm Sorry for the text only link-I'm too new to hyperlink still), confirmed that "A "label" is a display of written, printed or graphic matter upon the immediate container of any article."

It seems like I can make my compromise: Print "COMPANY C" on the device and print "Manufactured for Company C" on the Label and IFU.

Does this sound right?

Thanks in advance!
 
M

MIREGMGR

#19
The FDA's guidance assumes that the legally required labeling information is provided one time per unit of product...either on the product itself, or if necessary on the product unit packaging. Your question proposes a situation where there is some information that you regard as labeling on the product, and also a separate label on the package. I don't understand your circumstance well enough to grasp how it would be reconciled with the fundamental one-label concept.
 
A

AJayC

#20
I have the following situation for a Class II 510K product - Widget.

  • Company A - Manufacturer, Widget is Class I 510K Exempt
  • Company B - Private Labeler obtains a Class II 510K due to intended use change for the Widget, places own company name/brand on product labeling.
  • Company C - a potential Private Labeler of Company B's Class II Widget
Does the FDA require "Company B" to obtain written permission from "Company A" to sell widget to "Company C" as a private label product?
:confused:

From what I've read in these posts "Company C" would need to use "Manufactured for" or "Distributed by" on their private label.

Thanks for your help.
April
 
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