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VALID Act of 2023

USA118th CongressHR-2369| House 
| Updated: 4/7/2023
Larry Bucshon

Larry Bucshon

Republican Representative

Indiana

Cosponsors (3)
Thomas H. Kean (Republican)Anna G. Eshoo (Democratic)Diana DeGette (Democratic)

Ways and Means Committee, Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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.
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Timeline

Bill from Previous Congress

HR 116-6102
VALID Act of 2020

Bill from Previous Congress

HR 117-8616
VALID Act of 2022

Bill from Previous Congress

HR 117-4128
VALID Act of 2021
Mar 29, 2023
Introduced in House
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.
Apr 7, 2023
Referred to the Subcommittee on Health.
May 22, 2024

Latest Companion Bill Action

S 118-4387
Introduced in Senate
  • Bill from Previous Congress

    HR 116-6102
    VALID Act of 2020


  • Bill from Previous Congress

    HR 117-8616
    VALID Act of 2022


  • Bill from Previous Congress

    HR 117-4128
    VALID Act of 2021


  • March 29, 2023
    Introduced in House


  • March 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.


  • April 7, 2023
    Referred to the Subcommittee on Health.


  • May 22, 2024

    Latest Companion Bill Action

    S 118-4387
    Introduced in Senate

Health

VALID Act of 2023

USA118th CongressHR-2369| House 
| Updated: 4/7/2023
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.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline

Bill from Previous Congress

HR 116-6102
VALID Act of 2020

Bill from Previous Congress

HR 117-8616
VALID Act of 2022

Bill from Previous Congress

HR 117-4128
VALID Act of 2021
Mar 29, 2023
Introduced in House
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.
Apr 7, 2023
Referred to the Subcommittee on Health.
May 22, 2024

Latest Companion Bill Action

S 118-4387
Introduced in Senate
  • Bill from Previous Congress

    HR 116-6102
    VALID Act of 2020


  • Bill from Previous Congress

    HR 117-8616
    VALID Act of 2022


  • Bill from Previous Congress

    HR 117-4128
    VALID Act of 2021


  • March 29, 2023
    Introduced in House


  • March 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.


  • April 7, 2023
    Referred to the Subcommittee on Health.


  • May 22, 2024

    Latest Companion Bill Action

    S 118-4387
    Introduced in Senate
Larry Bucshon

Larry Bucshon

Republican Representative

Indiana

Cosponsors (3)
Thomas H. Kean (Republican)Anna G. Eshoo (Democratic)Diana DeGette (Democratic)

Ways and Means Committee, Health Subcommittee, Energy and Commerce Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted