Rapid assessment tests intended to ensure proper reprocessing

(a) Inclusion in device definition Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended— (1) in paragraph (h)(1)— (A) in clause (B), by striking or at the end; (B) in clause (C), by striking and at the end and inserting or; and (C) by inserting after clause (C) the following: (D) a rapid assessment test intended to ensure the proper reprocessing of a reusable device (as defined in paragraph (tt)), and; and (2) by adding at the end the following: (tt) The term reusable device means a device that— (1) is intended to be used more than one time; and (2) must be sanitized (whether through cleaning, disinfection, or sterilization) to ensure that the device is safe and effective for such intended use.. (b) Instructions for use and validation data Section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360), as amended by sections 2 and 3 of this Act, is further amended by adding at the end the following: (t) Instructions for use and validation data (1) Initial list Not later than 1 year after the date of enactment of this subsection, the Secretary shall by regulation develop and publish a list of types of rapid assessment tests described in section 201(h)(1)(D) for which reports under subsection (k) must include— (A) instructions for use that have been validated in a manner specified by the Secretary; and (B) validation data, of the types specified by the Secretary. (2) Updates The Secretary shall by regulation periodically update the list required by paragraph (1). (3) Enforcement Beginning on the date of publication of the initial list under paragraph (1), the Secretary shall not accept any notification under subsection (k) for clearance of a type of rapid assessment test that is included on such list unless such notification includes instructions for use and validation data in accordance with paragraph (1)..