classification of the accessory. If the Secretary does not agree with the recommendation for classification submitted by the sponsor, the response shall include a detailed description and justification for such determination to disagree. The Secretary shall provide an opportunity for a manufacturer to meet with appropriate personnel to discuss appropriate classification of such accessory prior to submitting a written recommendation. (E) At the time a sponsor submits an application for premarket approval for a class III device pursuant to section 515(c), the sponsor of such application may include a recommendation and supporting information for the proper classification of such accessory pursuant to subparagraph (A). If such device is intended to be used with an accessory that has not been classified by the Secretary based on its intended use or uses as described in subparagraph (A) or (C), the Secretary shall— (i) approve or deny the application pursuant to section 515(d)