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Or a Business Headquartered Outside the United States PRA Statement: See page 3. Section I Information about the Business Requesting Small Business Status 1. Name of business requesting MDUFA Small Business status: 2. Taxpayer Identification Number: 3. Address where business is physically located: 5. Your telephone number (Include country code & area code): 4. Name of person making this Certification: Check one response: Head of Firm 6. Your mailing address: Chief Financial Officer.

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552a Related content

FORM FDA 3602
has only the affiliates listed in this Certification, and together with those affiliates...
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RegulatoryInformation Questions & Answers

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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.

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.

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).

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.

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.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232