; table of contents. Sec. 2. Definitions. Sec. 3. Regulation of in vitro clinical tests. SUBCHAPTER J—In Vitro Clinical Tests SUBCHAPTER J. In Vitro Clinical Tests Sec. 587. Definitions. Sec. 587A. Applicability. Sec. 587B. Premarket review. Sec. 587C. Breakthrough in vitro clinical tests. Sec. 587D. Technology certification. Sec. 587E. Mitigating measures. Sec. 587F. Regulatory pathway redesignation. Sec. 587G. Advisory committees. Sec. 587H. Request for informal feedback. Sec. 587I. Registration and listing. Sec. 587J. Test design and quality requirements. Sec. 587K. Labeling requirements. Sec. 587L. Adverse event reporting. Sec. 587M. Corrections and removals. Sec. 587N. Restricted in vitro clinical tests. Sec. 587O. Appeals. Sec. 587P. Accredited persons. Sec. 587Q. Recognized standards. Sec. 587R. Investigational use. Sec. 587S. Collaborative communities for in vitro clinical tests. Sec. 587T. Comprehensive test information system. Sec. 587U. Preemption. Sec. 587V. Adulteration. Sec. 587W. Misbranding. Sec. 587X. Postmarket surveillance. Sec. 587Y. Electronic format for submissions. Sec. 587Z. Postmarket remedies. Sec. 4. Enforcement and other provisions. Sec. 5. Transition. Sec. 6. Emergency use authorization. Sec. 7. Antimicrobial susceptibility tests. Sec. 8. Combination products. Sec. 9. Resources. . 2. Definitions (a) In general Section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 ) is amended— (1) by adding at the end the following: (ss) (1) The term in vitro clinical test — (A) means a test intended by its developer (as defined in section 587) to be used in the collection, preparation, analysis, or in vitro clinical examination of specimens taken or derived from the human body for the purpose of— (i) identifying or diagnosing a disease or condition; (ii) providing information for diagnosing, screening, measuring, detecting, predicting, prognosing, analyzing, or monitoring a disease or condition, including by making a determination of an individual’s state of health