ensure compliance with applicable requirements in this subsection. 587L. Adverse event reporting (a) Applicability (1) In general Each in vitro clinical test developer shall establish and maintain a system for reporting adverse events in accordance with subsection (b), except as provided in section 587A. (2) Regulations The Secretary shall promulgate regulations to implement this section, including information necessary to be reported to ensure the analytical and clinical validity of in vitro clinical tests, and the safety of articles for taking or deriving specimens from the human body. (b) Adverse Event Reporting Requirements Each developer shall report to the Secretary whenever information that reasonably suggests that one of the developer's in vitro clinical tests is associated with an adverse event becomes known to the developer. (c) Reports Reports required under this section shall be submitted as follows: (1) An individual adverse event report shall be submitted for the following events not later than— (A) 5 calendar days after an in vitro clinical test developer receives or otherwise becomes aware of information that reasonably suggests the adverse event involves a patient death