; (iii) a risk assessment of the test; and (iv) a description of how the data and information in the application constitute valid scientific evidence and support a showing that the test meets the applicable standard under section 587(2). (C) The signature of the developer filing the premarket application or an authorized representative. (D) A bibliography of applicable published reports and a description of any studies conducted, including any unpublished studies related to such test, that are known or that should reasonably be known to the applicant, and a description of data and information relevant to the evaluation of whether the test meets the applicable standard. (E) Applicable information regarding the methods used in, and the facilities or controls used for, the development of the test to demonstrate compliance with the applicable quality requirements under section 587K. (F) Information demonstrating compliance with any relevant and applicable— (i) mitigating measures under section 587E; and (ii) standards established or recognized under section 514 prior to the date of enactment of the VALID Act of 2023 , or, after applicable standards are established or recognized under section 587R, with such standards. (G) Valid scientific evidence to support that the test meets the applicable standard, which shall include— (i) summary information for all supporting validation studies performed, including a description of the objective of the study, a description of the experimental design of the study, a description of any limitations of the study, a brief description of how the data were collected and analyzed, a brief description of the results of each study, and conclusions drawn from each study; (ii) raw data for each study, which may include, as applicable, tabulations of data and results