an exception or alternative to any provision listed in this section, unless explicitly required by a statutory provision outside this subchapter, for specified lots, batches, or other units of an in vitro clinical test, if the Secretary determines that compliance with such labeling requirement could adversely affect the availability of such products that are, or will be, included in the Strategic National Stockpile under section 319F–2 of the Public Health Service Act. (2) Regulations The Secretary may issue regulations amending section 809.11 of title 21, Code of Federal Regulations (or any successor regulation) to apply in full or in part to in vitro clinical tests and in vitro clinical test developers. (f) Regulations The Secretary shall issue regulations related to standardized, general content and format for in vitro clinical test labeling pursuant to this subsection. 587M. Adverse event reporting (a) In general Each in vitro clinical test developer shall establish and maintain a system for establishing and maintaining records of adverse events and reporting adverse events in accordance with this section. (b) Submission of individual reports A developer shall submit an individual adverse event report not later than 5 calendar days after the developer receives or becomes aware of an adverse event that reasonably suggests that an in vitro clinical test may— (1) have caused or contributed to a patient or user death