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VALID Act of 2021

USA117th CongressHR-4128| House 
| Updated: 6/25/2021
Diana DeGette

Diana DeGette

Democratic Representative

Colorado

Cosponsors (1)
Larry Bucshon (Republican)

Health Subcommittee, Energy and Commerce 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

HR 116-6102
VALID Act of 2020
Jun 24, 2021

Latest Companion Bill Action

S 117-2209
Introduced in Senate
Jun 24, 2021
Introduced in House
Jun 24, 2021
Referred to the House Committee on Energy and Commerce.
Jun 25, 2021
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

    HR 116-6102
    VALID Act of 2020


  • June 24, 2021

    Latest Companion Bill Action

    S 117-2209
    Introduced in Senate


  • June 24, 2021
    Introduced in House


  • June 24, 2021
    Referred to the House Committee on Energy and Commerce.


  • June 25, 2021
    Referred to the Subcommittee on Health.

Health

Related Bills

  • S 117-2209: VALID Act of 2021

VALID Act of 2021

USA117th CongressHR-4128| House 
| Updated: 6/25/2021
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

HR 116-6102
VALID Act of 2020
Jun 24, 2021

Latest Companion Bill Action

S 117-2209
Introduced in Senate
Jun 24, 2021
Introduced in House
Jun 24, 2021
Referred to the House Committee on Energy and Commerce.
Jun 25, 2021
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

    HR 116-6102
    VALID Act of 2020


  • June 24, 2021

    Latest Companion Bill Action

    S 117-2209
    Introduced in Senate


  • June 24, 2021
    Introduced in House


  • June 24, 2021
    Referred to the House Committee on Energy and Commerce.


  • June 25, 2021
    Referred to the Subcommittee on Health.
Diana DeGette

Diana DeGette

Democratic Representative

Colorado

Cosponsors (1)
Larry Bucshon (Republican)

Health Subcommittee, Energy and Commerce Committee

Health

Related Bills

  • S 117-2209: VALID Act of 2021
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted