; and (iii) shall provide for notice to individuals subject to the risks associated with the use of such in vitro clinical test. In providing the notice required by this clause, the Secretary may use the assistance of health professionals who prescribed, ordered, or used such an in vitro clinical test for individuals. (4) Clarification The remedy provided by this subsection shall be in addition to remedies provided by subsections (b) and (c). . 4. Enforcement and other provisions (a) Prohibited acts Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ) is amended— (1) in paragraphs (a), (b), (c), (g), (k), (q), (r), and (y), by inserting in vitro clinical test, after device, each place it appears; (2) in paragraph (y) by inserting or 587P after section 523 each place it appears; and (3) by adding at the end, the following: (fff) (1) The introduction or delivery for introduction into interstate commerce of an in vitro clinical test in violation of section 587B(a). (2) The false, fraudulent, or deceptive claiming for an in vitro clinical test of an exemption from the premarket review required under section 587B. (3) When claiming an exemption under section 587A from the premarket review required under section 587B, the failure to maintain complete and accurate documentation for the exemption as required under section 587A or the failure to provide labeling required under section 587A. (4) With respect to an in vitro clinical test, the submission of any report that is required by or under this Act that is false or misleading in any material respect. (5) The making of a false, fraudulent, or materially deceptive analytical or clinical claim for an in vitro clinical test— (A) in any application, report, or notification submitted to the Secretary under this Act