; and (II) such appropriate information to support the recommendation as may be specified by the Secretary. (ii) The Secretary’s response under section 515(d) or section 510(n) (as applicable) to an application or report described in clause (i) shall also contain the Secretary’s approval or denial of the proposed classification of the accessory involved. (iii) The Secretary’s evaluation of an accessory under clause (i) shall constitute an order establishing a new classification for such accessory for the specified intended use or uses of such accessory and for any accessory with the same intended use or uses as such accessory. (E) (i) A manufacturer of an accessory that has been previously classified by the Secretary based on the intended use of another device with which such accessory is intended to be used, through the approval of such other device under section 515(c), the clearance of such device under section 510(k), or the submission of a petition for classification under section 513(f)(2), and that has not been classified by the Secretary in accordance with subparagraph (A), may make a written submission to the Secretary containing a recommendation for the appropriate classification of the accessory based on the intended use or uses of the accessory. Such submission may include appropriate information to support the recommendation as may be specified by the Secretary. (ii) The Secretary shall respond to a submission made under clause (i) not later than 60 days after receiving such submission by approving or denying the recommended classification of the accessory. The Secretary shall provide an opportunity for a manufacturer to meet with appropriate personnel of the Food and Drug Administration to discuss the appropriate classification of such accessory prior to making a written submission. (F) Nothing in this paragraph may be construed as precluding a manufacturer of an accessory from using the classification process described in section subsection (f)(2) to obtain classification of such accessory. . 3.