; (E) the covered product is not a banned device under section 516; and (F) there is a public health or unmet medical need for the covered product in the United States. (c) Safety and effectiveness (1) In general The Secretary— (A) may decline to grant reciprocal marketing approval under this section with respect to a covered product if the Secretary affirmatively determines that the covered product— (i) is a drug that is not safe and effective; or (ii) is a device for which there is no reasonable assurance of safety and effectiveness; and (B) may condition reciprocal marketing approval under this section on the conduct of specified postmarket studies, which may include such studies pursuant to a risk evaluation and mitigation strategy under section 505–1. (2) Report to Congress Upon declining to grant reciprocal marketing approval under this section with respect to a covered product, the Secretary shall— (A) include the denial in a list of such denials for each month; and (B) not later than the end of the respective month, submit the list to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate. (d) Request A request for reciprocal marketing approval shall— (1) be in such form, be submitted in such manner, and contain such information as the Secretary deems necessary to determine whether the criteria listed in subsection (b)(2) are met