FDA MEDICAL DEVICE 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 2018  USD 4624.00    Pay directly to FDA        ------
     Total  $  
 

 

Submitter Name        Job Title        Submitter E-mail