under section 587I, in accordance with timely reporting requirements under this subchapter. (7) In the case of any in vitro clinical test subject to restrictions under section 587N, (1) if its advertising is false or misleading in any particular, (2) if it is offered for clinical use, sold, distributed, or used in violation of such restrictions, or (3) unless the test developer, manufacturer, or distributor includes in all advertisements and other descriptive printed matter that such person issues or causes to be issued, a brief statement of the intended uses of the in vitro clinical test and relevant warnings, precautions, side effects, and contraindications. This subsection shall not be applicable to any printed matter that the Secretary determines to be labeling as defined in section 201(m) or section 587K. (8) If it was subject to a mitigating measure established under section 587E, unless it bears such labeling as may be prescribed in such mitigating measure. (9) If it was subject to a standard established under section 587Q, unless it bears such labeling as may be prescribed in such standard. (10) Unless it bears such labeling as may be prescribed by or established under an applicable labeling requirement under this Act. (11) If there was a failure or refusal to comply with any requirement prescribed under section 587I or 587X, or to comply with a requirement under section 587Y, or to provide any report, material, or information required under this subchapter. 587X. Postmarket surveillance (a) In general (1) In general In addition to other applicable requirements under this Act, the Secretary may issue an order requiring a developer to conduct postmarket surveillance of a single in vitro clinical test as a condition of approval under section 587B. (2) Exempt tests The Secretary may order postmarket surveillance for tests exempt pursuant to section 587A for which the failure of the in vitro clinical test to meet the applicable standard for approval is likely to result in serious or adverse health