Can a Contract Manufacturer Delist a Device upon Discontinuation of Manufacturing?

Ajit Basrur

Staff member
Admin
#1
I have a question on medical device listing. As per https://www.fda.gov/MedicalDevices/...Device/RegistrationandListing/ucm053181.htm#3

Amongst certain examples, one of the change to listings include, a change to a previously listed device, such as where it is being manufactured.

My question is: does this mean that if the client pulled the "contract manufacturing" at supplier A, and transferred the contract manufacturing to supplier B, could the supplier A remove the device listing from its registration?

I have been hearing both instances, namely, yes, supplier A can remove the device its listing but on another side, it is said that the listing should be retained until the expiration of the manufactured device at supplier A's location.

Appreciate your thoughts. Thanks!
 
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Ajit Basrur

Staff member
Admin
#2
Re: Can a Contract Manufacturer Delist a Device upon Discontinuation of Manufacturing

Response from FDA:

If the contract manufacturer is no longer manufacturing the device, then they can deactivate the listing. Please keep in mind that the specifications developer should maintain its listing and include all proprietary names.
 
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