; and (II) do not alter— (aa) the intended use of the changed device; or (bb) the fundamental scientific technology of such device; (ii) manufacturing changes subject to a 30-day notice; (iii) changes that qualify for a Special PMA Supplement; and (iv) such other changes relating to the devices or the device manufacturing process as the Secretary determines appropriate; (B) the term in-scope device means a device within the scope of devices agreed to by the requestor and the accredited person for purposes of a request for certification under this section; (C) the term premarket notification means a premarket notification under section 510(k); (D) the term quality system means the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of devices, as described in section 520(f); (E) the term requestor means a device manufacturer that is seeking certification under this section of a quality system used by such manufacturer; (F) the term Special PMA means a Special PMA supplement under section 814.39(d) of title 21, Code of Federal Regulations (or any successor regulations); and (G) the term 30-day notice means a notice described in section 515(d)(5). (3) Accreditation process