Dear Anon,
It depends on what the relationship is between the two companies. Assuming this is United States? If your company develops the specifications and maintains the DHF, the other company is probably a supplier of a code development service and does not need to register. If the other company maintains the DHF and supplies only the finished software with your name on it, then they're likely in the contract manufacturer role and must register and list. If the relationship is more complicated, it will be important to define the expectations on each side with some precision.
The DHF section of the Design Control Guidance briefly mentions relationships between responsible manufacturers and code developers.
https://www.fda.gov/media/116573/download------------------------------
Anne LeBlanc
United States
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Original Message:
Sent: 12-Dec-2022 12:02
From: Anonymous Member
Subject: Medical Device Software Application Contract Manufacturer – FDA Establishment Registration
This message was posted by a user wishing to remain anonymous
Dear Forum,
A software development company is creating a software application for our medical device. It will be "labeled" with our company as the "manufacturer", with our UDI, and we will be listing the product under our device establishment registration. Does this software company need to also register and list?
Thank you for your response in advance!