; (B) relates to a change to the design of the device, a change to the recommended reprocessing protocols, if any, for the device, or a safety concern about the device; and (C) is widely disseminated (including on a voluntary basis) to health care providers in a foreign country. (3) Affiliate In this subsection, the term affiliate means a business entity that has a relationship with a second business entity if, directly or indirectly— (A) one business entity controls, or has the power to control, the other business entity; or (B) a third party controls, or has the power to control, both of the business entities. . 4. Rapid assessment tests intended to ensure proper reprocessing (a) Inclusion in device definition Section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 ) is amended— (1) in paragraph (h)— (A) in subparagraph (2), by striking or at the end; (B) in subparagraph (3), by striking and at the end and inserting or ; and (C) by inserting after subparagraph (3) the following: (4) a rapid assessment test intended to ensure the proper reprocessing of a reusable device (as defined in paragraph (ss)), and ; and (2) by adding at the end the following: (ss) The term reusable device means a device that— (1) is intended to be used more than one time