H.R. 2369 · 118th Congress

VALID Act of 2023

Introduced on Mar 29, 2023 by Larry Bucshon (R-IN-8). 3 cosponsors, 2 of them from another party. Latest action (Apr 7, 2023): Referred to the Subcommittee on Health.

Stage
Introduced
Introduced
Mar 29, 2023
Cosponsors
3
2 from the other party
Policy area
Health
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Progress

The furthest stage the measure reached. Simple and concurrent resolutions do not go to the President.

  1. Introduced
  2. 2Reported by committee
  3. 3Passed one chamber
  4. 4Passed both chambers
  5. 5Sent to the President
  6. 6Became law

Official title

To amend the Federal Food, Drug, and Cosmetic Act with respect to in vitro clinical tests, and for other purposes.

Summary

By the Congressional Research Service (Introduced in House, Mar 29, 2023). Public domain.

Verifying Accurate Leading-edge IVCT Development Act of 2023 or the VALID Act of 2023

This bill requires the Food and Drug Administration (FDA) to regulate in vitro clinical tests (IVCTs).

Currently, the FDA and the Centers for Medicare & Medicaid Services have authority to regulate in vitro diagnostic devices. The bill defines IVCTs, which includes in vitro diagnostic devices, as tests intended for the collection, preparation, analysis, or in vitro clinical examination of specimens from the human body to provide information about a disease, condition, or treatment.

An IVCT may not be introduced into interstate commerce unless it has received FDA premarket approval or is covered by certain exemptions, such as an exemption for a test that (1) was developed and introduced before this bill's enactment and meets certain requirements, (2) is a low-risk test, (3) is solely for public health surveillance, (4) is covered by a technology certification issued under this bill, or (5) has received a humanitarian exemption or emergency use authorization.

The FDA may grant upon application a technology certification. Generally, such a certification covers a group of tests that use a single technology and may be evaluated using a representative test. While such a certification is valid, a qualifying IVCT that falls within the scope of the certification shall be cleared for interstate commerce.

The bill also imposes various requirements related to IVCTs, including those related to quality control, labeling, and reporting adverse events.

The FDA shall have various enforcement authority, including authority to order the recall of an IVCT with a reasonable probability of causing serious adverse health consequences.

Sponsor and cosponsors

Cosponsors by party as of the day they signed on. Original cosponsors signed on the day of introduction.

Larry BucshonR-IN-8Sponsor

Democrats · 2

Republicans · 1

Roll calls

Recorded votes on the measure. Most measures move by voice vote or unanimous consent, which record no individual positions.

No recorded roll call on this measure: it moved by voice vote or unanimous consent, or has not reached the floor.

History

Every action as published, oldest first. Roll calls link to how each member voted.

  1. Mar 29, 2023Introduced in House
  2. Mar 29, 2023Introduced in House
  3. Mar 29, 2023 · HouseReferred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
  4. Mar 29, 2023 · HouseReferred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
  5. Apr 7, 2023 · HouseReferred to the Subcommittee on Health.

Committees

Committees and subcommittees the measure was referred to.

Agencies in its committees' jurisdiction

Analisa's mapping of committee jurisdiction to federal agencies; the bill may touch others, or none of these.

Who lobbied on it

Organizations whose lobbying reports (LD-2) name this measure. Spending is what they reported for those quarters on all issues, not on this measure alone.

  1. Advanced Medical Technology Association (AdvaMed)15 reports
    $740K reported (all issues)
  2. ROCHE DIAGNOSTICS CORPORATION8 reports
    $140K reported (all issues)Federal contractor: ROCHE DIAGNOSTICS CORPORATION$89.1M in contracts, FY2026AI match · 100%
  3. ADVANCED MEDICAL TECHNOLOGY ASSN5 reports
    $4.5M reported (all issues)
  4. ARUP Laboratories, Inc.5 reports
    $150K reported (all issues)Federal contractor: ARUP LABORATORIES INC$10.9M in contracts, FY2026AI match · 100%
  5. Association for Molecular Pathology5 reports
    $344K reported (all issues)
  6. Association of American Medical Colleges5 reports
    $3.1M reported (all issues)Federal contractor: ASSOCIATION OF AMERICAN MEDICAL COLLEGESAI match · 100%
  7. CARDINAL HEALTH INC.5 reports
    $2.3M reported (all issues)Federal contractor: CARDINAL HEALTH 200, LLC$276.6M in contracts, FY2026AI match · 100%
  8. Coalition for Innovative Laboratory Testing, Inc.5 reports
    $9,000 reported (all issues)
  9. Foundation Medicine, Inc.5 reports
    $500K reported (all issues)Federal contractor: FOUNDATION MEDICINE, INC.$19.2M in contracts, FY2026AI match · 100%
  10. HealthCare Institute of New Jersey5 reports
    $273.7K reported (all issues)
  11. MEDICAL DEVICE MANUFACTURERS ASSOCIATION5 reports
    $1.5M reported (all issues)
  12. Mayo Collaborative Services, Inc.5 reports
    $290K reported (all issues)Federal contractor: MAYO COLLABORATIVE SERVICES, INC.$5.2M in contracts, FY2026AI match · 100%
  13. QUEST DIAGNOSTICS INCORPORATED5 reports
    $2.3M reported (all issues)Federal contractor: QUEST DIAGNOSTICS INCORPORATED$67.1M in contracts, FY2026AI match · 100%
  14. Thermo Fisher Scientific Inc.5 reports
    $2.2M reported (all issues)Federal contractor: THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC$2.2M in contracts, FY2026AI match · 100%
  15. University of New Mexico5 reports
    $180K reported (all issues)Federal contractor: UNIVERSITY OF NEW MEXICO$5.4M in contracts, FY2026AI match · 100%
  16. University of Utah5 reports
    $270K reported (all issues)Federal contractor: UNIVERSITY OF UTAH$21.3M in contracts, FY2026AI match · 100%
  17. ABBOTT LABORATORIES4 reports
    $4.2M reported (all issues)Federal contractor: ABBOTT LABORATORIES INC.$90M in contracts, FY2026AI match · 100%
  18. American Medical Technologists4 reports
    $40K reported (all issues)
  19. Sanford Health4 reports
    $320K reported (all issues)Federal contractor: SANFORD HEALTH$34.5K in contracts, FY2026AI match · 100%
  20. American Clinical Laboratory Assn3 reports
    $1.5M reported (all issues)
  21. American Clinical Laboratory Association (ACLA)3 reports
    $150K reported (all issues)
  22. BECTON, DICKINSON AND COMPANY3 reports
    $2M reported (all issues)Federal contractor: BECTON, DICKINSON AND COMPANY$12.6M in contracts, FY2026AI match · 100%
  23. COLLEGE OF AMERICAN PATHOLOGISTS3 reports
    $496.8K reported (all issues)Federal contractor: COLLEGE OF AMERICAN PATHOLOGISTS$18M in contracts, FY2026AI match · 99%
  24. Columbia University3 reports
    $140K reported (all issues)
  25. F. Hoffmann-La Roche Ltd3 reports
    $410K reported (all issues)
  26. HEALTHCARE ASSOCIATION OF NYS3 reports
    $340K reported (all issues)Federal contractor: HEALTHCARE ASSOCIATION OF NEW YORK STATE, INC.AI match · 100%
  27. Invitae Inc.3 reports
    $205K reported (all issues)Federal contractor: INVITAE CORPORATIONAI match · 100%
  28. BIOMARIN PHARMACEUTICAL INC.2 reports
    $650K reported (all issues)
  29. BIOMERIEUX2 reports
    $390K reported (all issues)Federal contractor: BIOMERIEUX INC$49.4M in contracts, FY2026AI match · 100%
  30. ILLUMINA, INC.2 reports
    $680K reported (all issues)Federal contractor: ILLUMINA, INC.$21.9M in contracts, FY2026AI match · 100%
  31. Laboratory Access & Benefits (LAB) Coalition2 reports
    $20K reported (all issues)
  32. The Children's Hospital of Philadelphia2 reports
    $260K reported (all issues)Federal contractor: THE CHILDREN'S HOSPITAL OF PHILADELPHIA$177.5K in contracts, FY2026AI match · 100%
  33. Adaptive Biotechnologies1 report
    $30K reported (all issues)Federal contractor: ADAPTIVE BIOTECHNOLOGIES CORPORATION$308.9K in contracts, FY2026AI match · 100%
  34. Biodesix, Inc.1 report
    $30K reported (all issues)Federal contractor: BIODESIX, INC$153.2K in contracts, FY2026AI match · 100%
  35. CENTER FOR SCIENCE IN THE PUBLIC INTEREST1 report
    $22K reported (all issues)
  36. NATIONAL MARROW DONOR PROGRAM1 report
    Federal contractor: NATIONAL MARROW DONOR PROGRAM$27.8M in contracts, FY2026AI match · 100%
  37. NMDP (formerly known as National Marrow Donor Program)1 report
    $110K reported (all issues)
  38. SIEMENS MEDICAL SOLUTIONS USA INC.1 report
    $530K reported (all issues)Federal contractor: SIEMENS MEDICAL SOLUTIONS USA, INC.AI match · 100%
  39. The Coalition for 21st Century Medicine1 report
    $50K reported (all issues)

Reports filed in 2023, 2024.

Sources and method

Every figure on this page traces to these records.

  • Bill status: bills and resolutions, sponsors, actions, subjects and CRS summaries (U.S. Government Publishing Office (GovInfo), from Congress.gov (Library of Congress))GovInfo Bill Status bulk data (Congress.gov; summaries by the Congressional Research Service) · data current to Oct 3, 2026 · loaded Oct 3, 2026 · license: Public domain (U.S. Government work, 17 U.S.C. § 105)
  • Members of Congress, their terms, committees and identifiers (The @unitedstates project (from the Biographical Directory of the U.S. Congress, the House and the Senate))unitedstates/congress-legislators: legislators, committees and current committee membership · data current to Oct 3, 2026 · loaded Oct 3, 2026 · license: CC0 1.0 (public domain dedication)
  • House roll-call votes (Office of the Clerk, U.S. House of Representatives)Office of the Clerk, U.S. House of Representatives, roll-call vote records · data current to Oct 3, 2026 · loaded Oct 3, 2026 · license: Public domain (U.S. Government work, 17 U.S.C. § 105)
  • Senate roll-call votes and DW-NOMINATE scores (Voteview (UCLA Department of Political Science))Lewis, Jeffrey B., Keith Poole, Howard Rosenthal, Adam Boche, Aaron Rudkin, and Luke Sonnet (2026). Voteview: Congressional Roll-Call Votes Database. https://voteview.com/ · data current to Oct 3, 2026 · loaded Oct 3, 2026 · license: Free to use with the required citation
  • Lobbying disclosures (LD-1 registrations, LD-2 quarterly reports, LD-203 contribution reports) (Clerk of the U.S. House of Representatives)Clerk of the House, Lobbying Disclosure Act filings (organizations only; lobbyists' names are not loaded) · data current to Oct 6, 2026 · loaded Oct 6, 2026 · license: Public domain (U.S. Government work, 17 U.S.C. § 105)
  • Positions are shown only where a roll call recorded them; voice votes and unanimous consent record none.
  • Money and votes are shown side by side; neither explains the other.