; and (ii) provide such documentation to the Secretary upon request or inspection. (E) Guidance Not later than 30 months after the date of enactment of the VALID Act of 2023 , the Secretary shall issue guidance regarding the in vitro clinical tests that are modified and exempt from premarket review under section 587B pursuant to this paragraph. Such guidance shall include considerations for changes to a specimen type that may be made by a developer without the requirement of premarket review under 587B. (b) Manual tests (1) Exemption An in vitro clinical test is exempt from all requirements of this subchapter if the output of such in vitro clinical test is the result of direct, manual observation, without the use of automated instrumentation or software for intermediate or final interpretation, by a qualified laboratory professional, and such in vitro clinical test— (A) is developed and used within a single clinical laboratory for which a certificate is in effect under section 353 of the Public Health Service Act that meets the requirements under section 353 for performing high-complexity testing; (B) is not a specimen receptacle, instrument, or an in vitro clinical test that includes an instrument or specimen receptacle that is not approved under or exempt from section 587B; (C) is not a high-risk test, or is a high-risk test that the Secretary has determined meets at least one condition in paragraph (2) and is otherwise appropriate for this exemption