Hello,
The first comment would like to make is ensure whatever Company B is doing, the IFU and use of device being 'different than Company As' is still within the indications for use statement of the original 510(k) submission. Company B should be aware the IFU cleared under the 510(k) is what FDA expects to follow along with what is on the market. So if the use is different make sure indeed the indications are the same as you said and it is not "stretched."
To answer your question, technically if Company B is putting their name on the product, private label or not, they are deemed the legal manufacturer so they would be responsible for the risk management, and any other technical information related to the product. What this means is if Company A is the original manufacturer then there should be a really good contract in place describing who is responsible for what, and more importantly who manages the actual device changes and regulatory status. What this means is if Company B wants to make some changes to the IFU or labelling there should be clear communication between the two companies.
The second question depends on who is taking that responsibility, maybe assuming Company A. This again is why a good contract needs to be in place between the companies because if there are changes made the private labeller also needs to be aware of any changes made to the device. Since Company A is indicated to have the 510(k) for the products, it would be assumed they would take the bulk of the regulatory responsibilities.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 29-Jun-2020 15:59
From: Anonymous Member
Subject: OEM/Private Label IFU and Usability
This message was posted by a user wishing to remain anonymous
Hello -
I have a potential scenario I would like to get feedback on:
Company A has a 510(k) for a family of products. Within that 510(k) one of the products is manufactured for Company B. The product is labeled for Company B and the IFU & label content is provided by Company B. Company Bs IFU and use is different than Company As (intended use and indications are the same).
Which company is responsible to ensure Risk Management is captured for Company Bs IFU & Labeling?
How does this situation get documented in a letter to file or a new submission if changes were ever to occur?
Thank you!