; or (B) in the labeling or advertising of an in vitro clinical test. (6) The failure to comply with a condition of approval, performance standard, mitigating measure, or restriction established in an order approving an application or supplement under section 587B; the failure to perform a risk analysis required by section 587B; the failure to submit an annual report required under section 587B(k); or the failure to complete postmarket studies required under section 587V. (7) The marketing of an in vitro clinical test in violation of— (A) an order issued by the Secretary under section 587A; or (B) any requirement under section 587A. (8) With respect to technology certification under section 587D, the refusal to permit, or unreasonable delay in permitting, an inspection authorized under section 587D(f)(3)(G); the failure to comply with applicable requirements to submit an application or report under section 587D(e); or the failure to comply with applicable maintenance requirements under section 587D(h). (9) The failure to comply with an applicable mitigating measure established under section 587E or to maintain the documentation required under section 587E(b); or the failure to comply with a performance standard established under section 587Q. (10) The failure to register in accordance with section 587I, the failure to provide information required under section 587I(b), or the failure to maintain or submit information required under section 587I(c). (11) The failure to submit a report required under section 587L or 587M; the failure to comply with a restriction imposed under section 587N; or the failure to comply with labeling and advertising requirements under section 587N(b). (12) The failure to comply with the requirements of section 587P (relating to accredited persons). (13) The failure to comply with any requirement prescribed or established under section 587R; the failure to furnish any notification, information, material, or report required under section 587R