Medical Device Contract Manufacturer - Does the CM need to register with FDA?

#1
Hi,
A medical device contract manufacturer (CM) located outside US is responsible for finished device manufacturing but does not plan for distribution in US. The CM supplies to the OEM located in US. The OEM is responsible for distribution.

Does the CM need to register with FDA? Does the CM need to appoint a US agent? What are the product liability clauses applicable to CM?

Please help...

Thanks In advance
 
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#3
Hi,
A medical device contract manufacturer (CM) located outside US is responsible for finished device manufacturing but does not plan for distribution in US. The CM supplies to the OEM located in US. The OEM is responsible for distribution.

Does the CM need to register with FDA? Does the CM need to appoint a US agent? What are the product liability clauses applicable to CM?

Please help...

Thanks In advance
YES for your establishment registration, and that will need an US agent.
Your QMS must be in line with the 21 CFR 820.
You may be inspected by FDA at their own discretion
You have to list the devices you make and ship to your OEM in USA using the 510k number of your OEM, and put your status as Contract manufacturer. You will then have a listing number (D number) unique to your listing which will be generated in the FDA portal upon successful lisitng, and you may have to keep this listing number for each device known to you and share with your OEM when asked at any point of time.
You will also have your establishment registration number, and you will have to renew the registration annually before Dec for the successive year by payment of the prescribed fee which will be known well in advance. The fee is not the same each year.
Please also check with your OEM how you need to use these numbers in your shippment invoice to them.
 

LUFAN

Involved In Discussions
#4
As of a Final rule in 2012, yes.

Elimination of Registration and Listing Exemptions for Contract Manufacturers and Sterilizers Who Do Not Commercially Distribute the
Devices
Under current § 807.20(a)(2), (c)(1), and (c)(2), contract manufacturers and contract sterilizers are exempt from registration and listing obligations if they make or sterilize a device according to another person’s specifications for commercial distribution by the person who
developed the specifications. This final rule will eliminate the exemption from registration and listing for contract manufacturers and contract sterilizers who do not commercially distribute. Contract manufacturers and contract sterilizers not currently registering will be required to do so. Registration and listing is a recurring obligation, so there are annual costs associated with this impact .

According to federal register Vol. 77 No.149:
<https://www.govinfo.gov/content/pkg/FR-2012-08-02/pdf/2012-18764.pdf>

Another good FDA reference in addition to the one @somashekar referenced: Overview of Device Regulation
 
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