; and (3) in subsection (g)— (A) in paragraph (1), by inserting , in vitro clinical test, after device each place it appears; and (B) in paragraph (2)— (i) in subparagraph (A), by inserting , in vitro clinical test, after device ; and (ii) in subparagraph (B), by inserting or in vitro clinical test after device each place it appears. (d) Debarment, temporary denial of approval, and suspension Section 306 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 335a ) is amended by adding at the end the following: (n) In vitro clinical tests; mandatory debarment regarding third-Party inspections and reviews (1) In general If the Secretary finds that a person has been convicted of a felony for a violation of section 301(gg) or 301(fff)(1), the Secretary shall debar such person from being accredited under section 587Q and from carrying out activities under an agreement described in section 803(b). (2) Debarment period The Secretary shall debar a person under paragraph (1) for the following periods: (A) The period of debarment of a person (other than an individual) shall not be less than 1 year or more than 10 years, but if an act leading to a subsequent debarment under such paragraph occurs within 10 years after such person has been debarred under such paragraph, the period of debarment shall be permanent. (B) The debarment of an individual shall be permanent. (3) Termination of debarment; judicial review