FDA Small Business Registration

[Priyanka]

Hi, Our company is a startup for medical devices based in U.S. We have an affiliate in India. We intend to register our U.S business and apply for a small business registration with the FDA.

1.Should I mention simply our Indian affiliate in Form 3602 and not be required to submit Form 3602A, or
2.should I submit Form 3602 for our U.S. firm and Form 3602A for our Indian affiliate company?

 

[Orca1]

Based on the FDA Guidance for Medical Device User Fee Small Business Qualification and Certification, as a U.S. business, you should submit Form FDA 3602 for your U.S. firm. This form is the MDUFA Small Business Certification Request for a Business Headquartered in the United States.

For your Indian affiliate, you should submit a separate Form FDA 3602A, which is the MDUFA Foreign Small Business Certification Request for a Business Headquartered Outside the United States. This form includes a National Taxing Authority Certification, which serves as authentication of the gross sales and receipts for that business/affiliate.

So, to answer your question, you should follow option 2: submit Form FDA 3602 for your U.S. firm and Form FDA 3602A for your Indian affiliate company.

Note that you must include the gross receipts or sales of all your affiliates with your own gross receipts or sales when you prepare your Form FDA 3602.

Guidance sources:
FDA Guidance, Medical Device User Fee Small Business Qualification and Certification: Guidance for Industry, Food and Drug Administration Staff and Foreign Governments, II. Overview
FDA Guidance, Medical Device User Fee Small Business Qualification and Certification: Guidance for Industry, Food and Drug Administration Staff and Foreign Governments, V. Guidance for Foreign Businesses

 

[robert.johnson]

When applying for small business designation, the FDA requires you to provide information about all affiliates. Affiliates are generally defined as businesses that are controlled by or under common control with the applicant company.

This form 'Form 3602 (Small Business Certification for Medical Device Company)' is used by U.S. businesses to certify their small business status. When filling out Form 3602, you need to include information about all domestic and foreign affiliates.

This form 'Form 3602A (Foreign Business Certification for Medical Device Company)' is specifically for foreign businesses that need to certify their small business status. This is usually not required if the foreign business is just an affiliate of the U.S. company applying for small business designation.

In summary, you should mention your Indian affiliate in Form 3602 and typically do not need to submit Form 3602A separately for the affiliate.