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VALID Act of 2021

USA117th CongressS-2209| Senate 
| Updated: 6/24/2021
Richard Burr

Richard Burr

Republican Senator

North Carolina

Cosponsors (2)
Mike Braun (Republican)Michael F. Bennet (Democratic)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Verifying Accurate Leading-edge IVCT Development Act of 2021 or the VALID Act of 2021 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

S 116-3404
VALID Act of 2020
Jun 24, 2021
Introduced in Senate
Jun 24, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Jul 29, 2022

Latest Companion Bill Action

HR 117-8616
Introduced in House
  • Bill from Previous Congress

    S 116-3404
    VALID Act of 2020


  • June 24, 2021
    Introduced in Senate


  • June 24, 2021
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • July 29, 2022

    Latest Companion Bill Action

    HR 117-8616
    Introduced in House

Health

Related Bills

  • HR 117-4128: VALID Act of 2021

VALID Act of 2021

USA117th CongressS-2209| Senate 
| Updated: 6/24/2021
Verifying Accurate Leading-edge IVCT Development Act of 2021 or the VALID Act of 2021 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

S 116-3404
VALID Act of 2020
Jun 24, 2021
Introduced in Senate
Jun 24, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Jul 29, 2022

Latest Companion Bill Action

HR 117-8616
Introduced in House
  • Bill from Previous Congress

    S 116-3404
    VALID Act of 2020


  • June 24, 2021
    Introduced in Senate


  • June 24, 2021
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • July 29, 2022

    Latest Companion Bill Action

    HR 117-8616
    Introduced in House
Richard Burr

Richard Burr

Republican Senator

North Carolina

Cosponsors (2)
Mike Braun (Republican)Michael F. Bennet (Democratic)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • HR 117-4128: VALID Act of 2021
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted