application reviews, findings, and recommendations (1) Requirements for premarket application (A) Review, finding, and recommendation requirements An accredited person receiving an application for premarket approval under section 587B shall either— (i) provide to the Secretary, together with the application for premarket approval submitted by the applicant, a recommendation based on a finding that the criteria for approval of the application under section 587B(e)(2)(A) are met and issue a copy of such finding to the applicant, which finding shall plainly state— (I) the basis for the accredited person’s finding that the criteria under section 587B(e)(2)(A) are met