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Requirements for Contract Manufacturers and Contract Sterilizers – Registration and Listing and the new User Fees

Recently, FDA sent you a letter entitled 'Establishment Registration Fees and Electronic Registration and Listing for Medical Device Establishments'. We would like to clarify information in that letter regarding the requirements for contract manufacturers and contract sterilizers.

Contract manufacturers and contract sterilizers who put the devices into commercial distribution will continue to have to register their establishment and list the devices. Beginning October 1, 2007, they must register and list electronically and also must pay a registration user fee in order to complete their registration. Contract manufacturers and contract sterilizers who do not put the devices they manufacture or sterilize on a contract basis into commercial distribution are not required to register their establishment, list the devices, or pay the registration user fee.

If you have any questions concerning these fees please contact mdi at info@mdiconsultants.com

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