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Requirements for Private Labeling a Class III (PMA) Medical Device in the US

tehuff

Involved In Discussions
#1
What are the requirements for private labeling a Class III (PMA) device in the US? There are 2 scenarios: 1) device itself is identical and only the label is changing to reflect the distributor's name instead of the manufacturer and 2) label changes as described in (1) and minor device modifications (eg. different packaging configuration or bottle).

Thanks!
 
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tehuff

Involved In Discussions
#3
Let me change my question a bit...hopefully someone out there has done this before. Does the manufacturer need to get approval for the private label device if the only difference is that the label is changed to reflect the new distributor/retailer? Is this a new device that requires a PMA supplement?
Thanks!
 
#4
I have a similar question to above.
What are the requirements for private labeling a Class III (PMA) IVD in the US? The device itself is identical and only the label is changing to reflect the distributor's name instead of the manufacturer. Can this be done? Anyone had any experience of how to do this?
 

indubioush

Quite Involved in Discussions
#5
Sec. 807.20 Who must register and submit a device list?

(a) An owner or operator of an establishment not exempt under section 510(g) .... including any person who:

(3) Repackages or relabels a device;



Sec. 807.81 When a premarket notification submission is required.

....

(2) The device is being introduced into commercial distribution for the first time by a person required to register, whether or not the device meets the criteria in paragraph (a)(1) of this section.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
I have a similar question to above.
What are the requirements for private labeling a Class III (PMA) IVD in the US? The device itself is identical and only the label is changing to reflect the distributor's name instead of the manufacturer. Can this be done? Anyone had any experience of how to do this?
By default all the manufacturer's responsibilities would fall to the (legal) person whose name and address appear on the labeling - the distributor in this case. I've heard of class II cases where the OEM (Contract Manufacturer) kept most responsibilities (if you search for old posts by MIREGMGR, sometime between 2010 and 2016, you might find something), but I'm not familiar with the class III situation in this context. I guess you need to carefully read 21 CFR part 814 first, and maybe look into PMA-related guidance.
 
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