H.R. 2369: VALID Act of 2023
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H.R. 2369: VALID Act of 2023
118th Congress · introduced 2023-03-29 · Health · Latest: Referred to the Subcommittee on Health.
federal
Follow this bill, step by step
- Where it came from: introduced 2023-03-29 · official record
- Who proposed it: Rep. Bucshon, Larry [R-IN-8] · what a sponsor is
- What happened next: no floor votes in our records yet. Why?
- Where it stands now: Referred to the Subcommittee on Health. Not final yet: this can still change. We check for updates every day.
- If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.
Official title
VALID Act of 2023
Plain summary
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.
Congressional Research Service summary (Introduced in House), quoted unchanged (nonpartisan). Read the source.
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A “Yea” vote
If it passes both chambers and is signed, it becomes law.
A “Nay” vote
If it is not passed, current law stays as it is.
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What does this mean? (plain words)
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Alternatives
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How did my representative vote? · This bill's floor votes
Officials and money
Sponsor: Rep. Bucshon, Larry [R-IN-8] · 3 cosponsors
Cost estimate: No cost estimate published yet.
Cosponsors on this site
Diana DeGette (D-CO), Thomas H. Kean, Jr. (R-NJ)
No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.
Words on this page, explained (3)
- Authorization
- A law that creates or continues a government program and says what it may do, often with a suggested spending ceiling. An authorization alone does not provide money; a separate appropriation does.
- Bill
- A proposed law. It becomes law only if it passes the legislature and is signed by the president or governor (or a veto is overridden).
- Exemption
- A rule that removes certain people, property or activities from a tax or requirement.
Plain meanings written from linked sources. All words.
Sources
- Congressional Research Service summary (Introduced in House)
- Congress.gov
- Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-118hr2369.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/118/hr>
Record fed-us-cong118-hr2369 · catalog fed-us-congress-bills-cong118 · updated 2026-11-15 by psicol fed-bills-cong118