FDA MEDICAL DEVICE REGISTRATION FORM



Establishment


Establishment Contact


Type of Operation


US Importer / Distributor (For Foreign Facility Only)


Manufacturer (For US Facility Only)


Medical Device - 1


Medical Device - 2


Medical Device - 3


Medical Device - 4


Medical Device - 5


Medical Device - 6


Description of Service and Cost
 Description of Service  Fees  Number of services  Total Fees
 Establishment Registration, US Agent/Official Correspondent.  USD 449.00
 (Annually)

       $  
 Device Listing (additonal devices)  USD 50/device
       $  
 Label Review (optional)
 USD 649/device        $  
 FDA Registration Fee for the Year 2021  USD 5546.00    Pay directly to FDA        ------
     Total  $