Reporting requirement for certain communications to foreign health care providers

(a) Adulteration Section 501 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351), as amended by section 2 of this Act, is further amended by inserting after paragraph (k) the following: (l) If it is a device with respect to which the manufacturer is in violation of the reporting requirement under section 510(s) (relating to communications to foreign health care providers).. (b) Requirement Section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360), as amended by section 2 of this Act, is further amended by adding at the end the following: (s) Reporting requirement for certain communications to foreign health care providers (1) Requirement The manufacturer of a device that is marketed in interstate commerce shall give written notice to the Secretary of any communication described in paragraph (2) not more than 5 calendar days after making such communication. (2) Communication described A communication is described in this paragraph if the communication— (A) is made by the manufacturer of the device or an affiliate of the manufacturer; (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..