DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug AdministrationOMB Number 09100508 Expiration Date: May 31, 2022MDUFA Foreign Small Business Certification RequestPRA Statement: See next page.For.
Open form follow the instructions
Easily sign the form with your finger
Send filled & signed form or save
How to fill out the FORM FDA 3602A. MDUFA Foreign Small Business online
Filling out the FORM FDA 3602A is a crucial step for businesses headquartered outside the United States seeking small business status under the Medical Device User Fee Act (MDUFA). This guide provides clear, step-by-step instructions to assist you in completing the form accurately and efficiently.
Follow the steps to successfully complete your MDUFA Foreign Small Business Certification Request.
- Press the ‘Get Form’ button to access the form. This will allow you to download and open the document in a suitable editor or PDF viewer.
- Identify the fiscal year for which your Small Business Certification Request applies. Enter this information at the top right section of the form header.
- In Section I, provide all information about the business requesting small business status, including the full legal name, Organization ID Number (Org ID), physical address, and key contact details.
- Continue in Section II by listing all affiliates (up to 5) along with their corresponding Taxpayer ID Numbers and Gross Receipts or Sales.
- Sum the Gross Receipts or Sales of all affiliates in Section II, and record the total in the provided space.
- Certify the accuracy of the information provided by completing, signing, and dating the certification statement at the end of Section II.
- For Section III, submit your completed form to your National Taxing Authority for their certification. Ensure they complete the required information.
- After receiving the completed form back from the National Taxing Authority, review it for completeness and accuracy. Then, print and sign the final version.
- Mail the finalized FORM FDA 3602A along with all necessary supporting documentation to the designated FDA address.
- Once your application is complete, monitor its status and keep copies of all documents submitted for your records.
Start filling out your FORM FDA 3602A online today to ensure timely processing of your small business certification.
Experience a faster way to fill out and sign forms on the web. Access the most extensive library of templates available.
Related content
Have you attached a separate MDUFA Foreign Small Business Certification Request or a U.S...
Get answers to your most pressing questions about US Legal Forms API.
What does a FDA do?
The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.
Do small businesses have to register with the FDA?
Facilities that manufacture, process, pack, or hold food that is intended for human or animal consumption in the United States must register with FDA before beginning these activities.
How do you register as a small business with the FDA?
Go to FURLS at https://.access.fda.gov/oaa/. If you have never previously registered a device establishment, you will need to first create a FURLS account for the owner/operator (See Types of FURLS Accounts below).
What is FDA small business?
A small business is defined as a business, including its affiliates, whose gross receipts and sales are less than $100 million for the most recent tax year.
How much is FDA small business registration fee?
FDA 2022 User Fee for Establishment Registration For FDA user fees 2022, the registration fee for each establishment is $5,672 (in United States dollars). There are no waivers or reductions for small establishments, businesses, or groups.
Use professional pre-built templates to fill in and sign documents online faster. Get access to thousands of forms.
If you believe that this page should be taken down, please follow our DMCA take down process here.