; and (ii) the assessment summary and certification of the quality system of a requestor shall be deemed accepted by the Secretary on such 30th day. (C) Actions by secretary (i) In general Within 30 days of receiving an assessment summary and certification under subparagraph (A), the Secretary may, by written notice to the accredited person submitting such assessment certification, deem any such certification to be provisional beyond such 30-day period, suspended pending further review by the Secretary, or otherwise qualified or cancelled, based on the Secretary’s determination that (as applicable)— (I) additional information is needed to support such certification; (II) such assessment or certification is unwarranted; or (III) such action with regard to the certification is otherwise justified according to such factors and criteria as the Secretary finds appropriate. (ii) Acceptance of certification If following action by the Secretary under clause (i) with respect to a certification, the Secretary determines that such certification is acceptable, the Secretary shall issue written notice to the applicable accredited person indicating such acceptance. (2) Notifications to Secretary by certified requestors or accredited persons for program evaluation purposes (A) Annual summary report for device-related changes otherwise subject to premarket notification A requestor whose quality system is certified under this section that effectuates device-related changes with respect to in-scope devices, without prior submission of a premarket notification, shall ensure that an annual summary report is submitted to the Secretary by the accredited person which— (i) describes the changes made to the in-scope device