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Where can I get a copy of FDA's Form 2891?

 

 
   

 

 

 

Form 2891 is used for Initial Device Establishment Registration 

You can download it from the FDA's website HERE

 

IMPORTANT:  It is important to follow these steps when filling out Form 2891, otherwise the FDA will reject your application.

 

  1. Complete the entire form online, using a typewriter, or by clearly hand printing the information.
  2. If you use your computer to complete the form, make sure you print off a copy before closing the file. Otherwise, you will lose all of your data. You will not be able to save the completed form unless you have a complete copy of the Adobe Acrobat software (this is not free). The printed form will include the question marks.
  3. Sign and make three photocopies of the original form.
  4. Submit the original form and three photocopies to FDA at:

    Registration and Listing Program, HFZ-308
    Division of Risk Management and Operations
    Office of Compliance
    Center for Devices and Radiological Health
    9200 Corporate Blvd.
    Rockville, MD 20850-4015
FDA will return your submission if you do not submit the required three photocopies and the original signed form.  To avoid any delays in processing your initial registration form FDA 2891, please submit the required number of photocopies.

 

   
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