The term “affiliate” is defined in Section 737(12) of the FD&C Act. An affiliate means a
business entity that has a relationship with a second business entity whether, directly or
indirectly:
- one business entity controls, or has the power to control, the other business entity; or
- a third-party controls, or has power to control, both of the business entities.
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 (MDUFA Small Business
Certification Request, for a Business Headquartered in the United States).
