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HR 2369 118th Congress House Health

VALID Act of 2023

Introduced: March 21, 2024 See on congress.gov
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This bill died when the 118th Congress ended
It never became law before the 118th Congress (2023–2024) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Apr 7, 2023
Referred to the Subcommittee on Health.
Mar 29, 2023
Referred 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.
Mar 29, 2023
Introduced in House
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 Plain-English summary Congressional Research Service

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.

What's happening now April 7, 2023

Referred to the Subcommittee on Health.

 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 3
 Lobbying activity 20

Registered lobbyists who named this bill in their disclosure filings. Source: federal Lobbying Disclosure Act filings.

See all 20 filings →
 Cosponsors 3
All 3 Democratic 1 Republican 1
Eshoo, Anna
· Mar 21, 2024
 R
Kean, Thomas H.
New Jersey · May 11, 2023
 D
DeGette, Diana
Colorado · Mar 29, 2023
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 2369: VALID Act of 2023. 118th Congress. Open America. https://openamerica.io/bill/118-HR-2369/
MLA
"H.R. 2369: VALID Act of 2023." 118th Congress, 2026, Open America, https://openamerica.io/bill/118-HR-2369/.
Bluebook (legal)
H.R. 2369, 118th Cong. (2026), https://openamerica.io/bill/118-HR-2369/.
Markdown link
[H.R. 2369: VALID Act of 2023](https://openamerica.io/bill/118-HR-2369/)
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