1. Short title (a) Short title This Act may be cited as the Verifying Accurate Leading-edge IVCT Development Act of 2023 or the VALID Act of 2023 . 2. Definitions (a) In general Section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 ) is amended— (1) by adding at the end the following: (ss) (1) The term in vitro clinical test means an article specified in subparagraph (2) that is intended to be used in the collection, preparation, analysis, or in vitro clinical examination of specimens taken or derived from the human body for the purpose of— (A) identifying or diagnosing a disease or condition; (B) providing information for diagnosing, screening, measuring, detecting, predicting, prognosing, analyzing, or monitoring a disease or condition, including by making a determination of an individual’s state of health; or (C) selecting, monitoring, or informing therapy or treatment for a disease or condition. (2) An article specified in this subparagraph is— (A) a test kit; (B) a test system; (C) a test protocol or laboratory test protocol; (D) an instrument (as defined in section 587(11)); (E) a specimen receptacle (as defined in section 587(17)); (F) software, excluding software that is excluded by section 520(o) from the definition of a device under section 201(h), that— (i) is a component or part of another in vitro clinical test or analyzes, processes, or interprets a signal or pattern from another in vitro clinical test; and (ii) does not analyze, process, or interpret a signal, pattern, or medical image from a device