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Code · BILL · 117th Congress · S. 4348 (Introduced in Senate) — To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs,... · Sec. 821

Sec. 821. Short title; table of contents

237 words·~1 min read·/bill/117/s/4348/is/section-821·

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This subtitle may be cited as the or the Food and Drug Administration Safety and Landmark Advancements Act of 2022 . VALID Act of 2022 The table of contents of this subtitle is as follows: SUBCHAPTER C—In Vitro Clinical Tests Sec. 821. Short title; table of contents. Sec. 822. Definitions. Sec. 823. Regulation of in vitro clinical tests. SUBCHAPTER J—In Vitro Clinical Tests SUBCHAPTER J. In Vitro Clinical Tests Sec. 587. Definitions. Sec. 587A. Regulation of in vitro clinical tests.
Sec. 587B. Premarket review. Sec. 587C. Exemptions. Sec. 587D. Technology certification. Sec. 587E. Mitigating measures. Sec. 587F. Regulatory pathway designation. Sec. 587G. Grandfathered in vitro clinical tests. Sec. 587H. Advisory committees. Sec. 587I. Breakthrough in vitro clinical tests. Sec. 587J. Registration and listing. Sec. 587K. Test design and quality requirements. Sec. 587L. Labeling requirements. Sec. 587M. Adverse event reporting. Sec. 587N. Corrections and removals.
Sec. 587O. Restricted in vitro clinical tests. Sec. 587P. Appeals. Sec. 587Q. Accredited persons. Sec. 587R. Recognized standards. Sec. 587S. Investigational use. Sec. 587T. Collaborative communities for in vitro clinical tests. Sec. 587U. Comprehensive test information system. Sec. 587V. Preemption. Sec. 587W. Adulteration. Sec. 587X. Misbranding. Sec. 587Y. Postmarket surveillance. Sec. 587Z. Electronic format for submissions. Sec. 587AA. Postmarket remedies. Sec. 587BB. Applicability.
Sec. 587CC. Judicial review. Sec. 824. Enforcement and other provisions. Sec. 825. Transition. Sec. 826. Emergency use authorization. Sec. 827. Antimicrobial susceptibility tests. Sec. 828. Combination products. Sec. 829. Resources.
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