Hello Anon,
In a simple answer no, because a Contract Manufacturer has different roles as defined by the FDA, being an entity which is only manufacturing a medical device for another company. There needs to be a company with their establishment registered as the Manufacturer. The Manufacturer then needs to list the product(s) on the Medical Device Listing. As the previous poster provided, then the Contract Manufacturer can add to their listing. These are not publicly available to be seen on the FDA's website, but on the "backside" of the FDA's database these are linked together. The Contract Manufacturer also need to have their establishment registered, because when the Manufacturer lists their medical device, there is a selection of who makes the device where then the Contract Manufacturer can be searched and then selected.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 03-Apr-2024 15:28
From: Anonymous Member
Subject: FDA registrations as Contract manufacturer and Legal Manufacturer
This message was posted by a user wishing to remain anonymous
The manufacturer or specification developer has to list it first, then the contract manufacturer can add it. I don't know what happens to the CM's listing if the manufacturer de-lists it.
https://www.fda.gov/medical-devices/device-registration-and-listing/frequently-asked-questions-about-new-device-registration-and-listing-requirements#foreign
Original Message:
Sent: 02-Apr-2024 19:51
From: Anonymous Member
Subject: FDA registrations as Contract manufacturer and Legal Manufacturer
This message was posted by a user wishing to remain anonymous
Is it possible for a 510(k) cleared device to only have a registration done by its contract manufacturer (where the FDA website lists the company as Contract manufacturer) while the Legal manufacturer (510(k) holder) is not registered with the product?