vitro clinical test and is exempt from most FDA regulation. This product must be evaluated by the in vitro clinical test developer in accordance with applicable requirements. . If the labeling of an analyte specific reagent bears the information set forth in this paragraph, it need not bear the information required by subsection (c)(1). (7) Over-the-counter test sample collection systems labeling The labeling for over-the-counter test sample collection systems for drugs of abuse testing shall bear the name and place of business of the developer included in the registration listing under section 587I, in language appropriate for the intended users. If the labeling of such over-the-counter test sample collection system bears the information set forth in this paragraph (4)(G), it need not bear the information required by subsection (c)(1). (e) Tests in the Strategic National Stockpile (1) In general The Secretary may grant an exception or alternative to any provision listed in this section, unless explicitly required by a statutory provision outside this section, 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 safety, effectiveness, or availability of such products that are or will be included in the Strategic National Stockpile. (2) Regulations The Secretary may issue regulations amending section 809.11 of title 21 of the 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) Guidance The Secretary may, in collaboration with developers, issue guidance on standardized, general content and format for in vitro clinical test labeling to help 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