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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.
- Complete the entire form online, using
a typewriter, or by clearly hand printing the information.
- 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.
- Sign and make three photocopies of the
original form.
- 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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