Labeling Requirements for Acquired Medical Device Inventory

[SylvieS]

A company A has bought a product line and the existing inventory from company B.
Company B delisted the product from their 510k listing.
Company A is not yet ready to manufacture the product (production line transfer not finished) but needs to continue distributing the device and would therefore list the new device.

However do they need to relabel the device under their own name or can they still distribute the device with the previous manufacturer's name on an FDA point of view ?

Thanks !

 

[Ronen E]

Hi SylvieS, welcome to the Cove discussions

I think it would be easiest/clearest to handle the distribution of that old inventory as a distributor who just purchased it from the manufacturer. In that case company A would have only distributor obligations with regards to that inventory (they could add their own sticker but are not obliged to do so). To close the regulatory loop, perhaps company A can put down in contract with company B that company B would continue to be responsible for the sold leftover inventory, at least formally (a practical arrangement can also be included in the contract), and would fully inform company A of any market feedback - especially complaints and adverse events - that they receive due to their details still appearing on the label.

When manufacturing recommences at company A, company A would have to take the full manufacturer role and labelling would have to match.

Of course, the value of the above suggestion depends on the nature of the devices, the quantity transferred vs. routine requirements, lifetime of the device, device risk level / volume of problems and market feedback etc. etc. What I suggested is more appropriate for lower-risk / shorter life / high volume turnover devices.

Cheers,
Ronen.

 

[SylvieS]

However while company B did delist the 510k... can Company A still distribute it ?