; (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 design and intended use, including the indications for use; and (iv) a description regarding test function and performance characteristics. (B) A summary of the data and information in the application for the in vitro clinical test, including— (i) 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a list of all countries in which the test has been marketed and a list of all countries in which the test has been withdrawn from the market for any reason related to the ability of the in vitro clinical test to meet the applicable standard, if known by the applicant; (ii) a description of benefit and risk considerations related to the in vitro clinical test, including a description of any applicable adverse effects of the test on health and how such adverse effects have been, or will be, mitigated; (iii) a risk assessment of the test