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Code · BILL · 117th Congress · H.R. 4128 (Introduced in House) — To amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of in vitro clinical tests, and for o... · Sec. 1

Sec. 1. Short title; table of contents

207 words·~1 min read·/bill/117/hr/4128/ih/section-1

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This Act may be cited as the or the Verifying Accurate Leading-edge IVCT Development Act of 2021 . VALID Act of 2021 The table of contents of this Act is as follows: Sec. 1. Short title; table of contents. Sec. 2. Definitions. Sec. 3. Regulation of 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.
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