; (ii) the table of contents for the application and the identification of the information the applicant claims as trade secret or confidential commercial or financial information; (iii) a description of the test’s intended use; (iv) an explanation regarding test function and any significant performance characteristics; and (v) an explanation of how the development and validation activities support the test meeting the applicable standard. (B) A summary of the data and information in the application for the in vitro clinical test, including— (i) a brief description of any existing alternative practices or procedures for diagnosing the disease or condition for which the in vitro clinical test is intended, as applicable; (ii) a brief description of the foreign and domestic marketing history of the test, if any, including a list of all countries in which the test has been marketed and a list of all countries in which the test has been withdrawn from marketing for any reason related to the applicable standard of the in vitro clinical test, if known by the applicant; (iii) a summary of the any studies submitted for such test, including a description of the objective of the study, a description of the experimental design of the study, a brief description of how the data were collected and analyzed, a brief description of the results of the technical data submitted, and a brief description of any nonclinical or clinical studies; (iv) a risk assessment of the test