Device Labeling "Manufactured for"

M

MIREGMGR

#21
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
There needs to be a shared and documented understanding of how Companies A and B are doing business. Note that how A and B are doing business should be consistent with how they've Listed their activities.

I think the most sensible approach is that Company A is acting as a contract manufacturer for Company B...selling them a finished device, in effect of company B's design since Company B has a different intended use than company A and the "design" from a regulatory perspective is how the device is made safe and effective for its intended use. Thus the product sold by Company A to Company B is not the medical device marketed by Company A.

Thus Company A would be Registered as a Manufacturer and a Contract Manufacturer, and would have a Listing for their exempt medical device. Company B would be Registered as a Specification Provider, and would have a Listing for their 510(k)ed medical device.

Does the FDA require "Company B" to obtain written permission from "Company A" to sell widget to "Company C" as a private label product?
First: FDA doesn't have any rules about business activities...only about product marketing. So, FDA doesn't care about the A, B and C relationship.

Second: Because the the product sold by Company A to Company B is not the medical device marketed by Company A, and Company A is a contract manufacturer for Company B, Company A normally (i.e. in common commercial practice) wouldn't have control over Company B's marketing.

However, business arrangements between private parties are a private matter. Company A could insist on such control as a condition of selling their product to Company B, and Company B would seem to have no choice but to accept that condition or walk away.

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