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MEDICAL DEVICE ESTABLISHMENT REGISTRATION FORM
Establishment
         
                 
     
     
     
Establishment Contact
    
                           
                
     
     
     
      
Type of Operation
Manufacturer               Contract Manufacturer                Contract Sterilizer                Specification Developer              Initial Importer             
Foreign Exporter            Relabeler        Other (Explain)
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 2017  USD 3382.00    Pay directly to FDA        ------
     Total  $  
 

 
Submitter Name        Job Title        Submitter E-mail