I am assuming that FPL means Final Package Label. Private labelling already can be a confusing and struggling topic - thank you for clarifying this is for the U.S. market because other markets like Canada, EU, Japan treat this differently. This is also assuming you are talking about finished medical devices (or combination products but medical devices as the "device").
An original equipment manufacturer or the original manufacturer of a device can make "Product A" which they can sell and distribute under their own name - the product being square, blue, company logo, name on box, name on front, etc. In the contact information, the label would read "Manufactured BY Company A". An original manufacturer can also private label a device making "Product B" which is made for Company B who Company B sell and distribute under their name - the product being rectangle, pink, Company B logo, Company B name on front and back, etc. In the contact information, the label would read "Manufactured FOR Company B". There are other things like establishment registrations and such but that is the fundamental difference - and most importantly Company B will be considered the legal manufacturer, take on all regulatory responsibilities, and Company A will be considered a Contract Manufacturer (OEM) or supplier by Company B. This can be complicated because a contract must exist (well should exist in a regulatory environment) between Company A and Company B that can specify other contractual agreements.
Now the situation you described is becoming more important especially in other places like Europe that is often referred to as "co-branding" where Company A makes the finished device, but Company A name is "on the back" that says "Manufactured BY Company A" and "on the front" is Company B's name, logo, colors, look and feel. In essence, when a customer buys the finished medical device, they see it as Company B's product, but on closer examination they could find out that it is actually made by another company. The idea with co-branding is that while the product looks and feels like Company B's product, Company A is still maintaining all (most) of the regulatory responsibilities. That way Company B who wants to private label the device, sell under their name, but they want minimal regulatory obligations. As you can imagine in this relationship a contract between Company A and Company B is extremely crucial to identify all of the roles, responsibilities, obligations, reporting, etc. from a regulatory perspective that needs to be all clearly defined in the contract as to who does what and who is responsible for regulatory actions, i.e. registrations, complaints, recalls, advisory notices, adverse events, returns.
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Richard Vincins RAC
Vice President Regulatory Affairs
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Original Message:
Sent: 22-May-2018 14:27
From: Anonymous Member
Subject: Private Labeling - Medical Device
This message was posted by a user wishing to remain anonymous
Assuming we are dealing with a U.S. market, please address the veracity of the following comment:
"Private label is not the same as having a customer's name put on the FPL. Private labeling means our name is taken off of the device."
P.S. - The company/manufacturer in question affixes customer name labels to the face plates of their devices, however, the company/manufacturer name is concurrently labeled on the back. This strikes me as a private label relationship -- because the named customer is placing the device on the market -- but others do not agree. Any help would be appreciated!