; (3) shall continue to apply with respect to device-related changes made during such 2-year period, provided the certification remains in effect, irrespective of whether such certification is renewed after such 2-year period; (4) shall have no effect on the need to comply with applicable submission requirements specified in subsection (a)(1)(C) with respect to any change pertaining to in-scope devices which is not a device-related change under subsection (a)(2); (5) shall have no effect on the authority of the Secretary to conduct an inspection or otherwise determine whether the requestor has complied with the applicable requirements of this Act; and (6) may be revoked by the Secretary upon a determination that the requestor’s quality system no longer meets the criteria specified in the guidance issued under subsection (a)(5) with respect to the in-scope devices at issue. (d) Notice of revocation The Secretary shall provide written notification to the requestor of a revocation pursuant to subsection (c)(6) not later than 10 business days after the determination described in such subsection. Upon receipt of the written notification, the requestor shall satisfy the applicable submission requirements specified in subsection (a)(1)(C) for any device-related changes effectuated after the date of such determination. After such revocation, such requestor is eligible to seek re-certification under this section of its quality system. (e) Program evaluation; sunset (1) Program evaluation and report (A) Evaluation The Secretary shall complete an evaluation of the third-party quality system assessment program under this section no later than January 31, 2021, based on— (i) analysis of information from a representative group of device manufacturers obtained from notifications provided by certified requestors or accredited persons under subsection (b)(2)