; (iv) a risk assessment of the test; and (v) conclusions drawn from any studies described in clause (iii), including a discussion demonstrating that the data and information in the application constitute valid scientific evidence and meet the applicable standard under section 587(10), an explanation of how the development and validation activities, as applicable, support that the test meets the applicable standard under section 587(10), and a discussion of any adverse effects of the test on health and proposals to mitigate those risks, if any. (C) The signature of the person filing the premarket application or an authorized representative. (D) A bibliography of all published reports reasonably known to the applicant related to such test and a discussion of data and information relevant to the evaluation of the applicable standard that may be met by such test. (E) A statement that the applicant believes to the best of the applicant’s knowledge that all data and information submitted to the Secretary are truthful and accurate and that no material fact has been omitted in the application. (F) Except as provided under subsection (d), applicable information regarding the methods used in, or the facilities or controls used for, the development of the test to demonstrate compliance with the applicable quality requirements under section 587J. (G) Information demonstrating compliance with any relevant— (i) mitigating measures under section 587E; and (ii) standards established or recognized under section 514 prior to the date of enactment of the Verifying Accurate Leading-edge IVCT Development Act of 2020 , or, after applicable standards are established or recognized under section 587Q, with such standards. (H) Valid scientific evidence to support analytical and clinical validity of the test, which shall include— (i) summary information for all supporting validation studies performed