installed, or imported in an establishment not duly registered under section 587J or it was not included in a listing under section 587J, in accordance with timely reporting requirements under this subchapter. (7) In the case of any in vitro clinical test subject to restrictions under section 587O, (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 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 indications for use of the in vitro clinical test and relevant warnings, precautions, side effects, and contraindications. This paragraph shall not be applicable to any printed matter that the Secretary determines to be labeling as defined in section 201(m). (8) If it is subject to a mitigating measure established under section 587E and does not bear such labeling as may be prescribed in such mitigating measure. (9) If it is subject to a standard established under section 587R and it does not bear such labeling as may be prescribed in such standard. (10) Unless it bears such labeling as may be required by or established under an applicable labeling requirement under this Act. (11) If there was a failure to comply with any requirement prescribed in or under section 587D, 587J, 587K, 587L, 587M, 587N, 587X, 587Y, 587Z, or to provide any report, material, or other information required with respect to in vitro clinical tests 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 of a high-risk or moderate-risk in vitro clinical test to conduct postmarket surveillance of such in vitro clinical test, if the failure of the in vitro clinical test is reasonably likely to result in serious adverse health consequences or death from use of