1. Short title This Act may be cited as the Quality Systems Certification Act of 2017 . 2. Third-party quality system assessment (a) Establishment of third-Party quality system assessment program Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 524A ( 21 U.S.C. 360n–1 ) the following new section: 524B. Third-party quality system assessment (a) Accreditation and assessment (1) In general; certification of device quality system The Secretary shall, in accordance with this section, establish a third-party quality system assessment program— (A) to accredit persons to assess whether a requestor’s quality system, including its design controls, can reasonably assure the safety and effectiveness of in-scope devices subject to device-related changes; (B) under which accredited persons shall (as applicable) certify that a requestor’s quality system meets the criteria included in the guidance issued under paragraph (5) with respect to the in-scope devices at issue; and (C) under which the Secretary shall rely on such certifications for purposes of determining the safety and effectiveness (or as applicable, substantial equivalence) of in-scope devices subject to the device-related changes involved, in lieu of compliance with the following submission requirements: (i) A premarket notification. (ii) A 30-day notice. (iii) A Special PMA supplement. (2) Definitions For purposes of this section─ (A) the term device-related changes means changes made by a requestor with respect to in-scope devices, which are— (i) changes to a device found to be substantially equivalent under sections 513(i) and 510(k) to a predicate device, that— (I) would otherwise be subject to a premarket notification; 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