; and (7) in paragraph (9)— (A) in subparagraph (C)(i), by striking or 520(g) and inserting 520(g), 587B, or 587D ; and (B) in subparagraph (D), by striking or 520 and inserting 520, 587B, or 587D . (b) Classification of products Section 563 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–2 ) is amended by adding at the end the following: (d) Exemption This section shall not apply to a product constituted of only a device and an in vitro clinical test. . 9. Resources (a) Findings Congress finds that the fees authorized by this section will be dedicated to meeting the goals identified in the letters from the Secretary of Health and Human Services to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record. (b) Establishment of user fee program (1) Development of user fees for in vitro clinical tests (A) In general Beginning not later than October 1, 2025, the Secretary of Health and Human Services (in this section referred to as the Secretary ) shall initiate the development of recommendations in accordance with this section to present to Congress with respect to the goals, and plans for meeting the goals, for the process for the review of in vitro clinical test submissions and applications under subchapter J of chapter V of the Federal Food, Drug, and Cosmetic Act, as added by this Act, for the first 4 fiscal years after fiscal year 2028 and for the authorization of the In Vitro Clinical Test User Fee Program for such fiscal years. In developing such recommendations, the Secretary shall consult with— (i) the Committee on Health, Education, Labor, and Pensions of the Senate; (ii) the Committee on Energy and Commerce of the House of Representatives; (iii) scientific and academic experts; (iv) health care professionals; (v) representatives of patient and consumer advocacy groups