Pipeline · Bill → Law
Step 1
Introduced
Mar 29, 2023
Step 2
Referred
Apr 7, 2023
E&C · Ways & Means
Step 3
Committee
Step 4
House floor
Step 5
Senate
Step 6
Resolve Changes
Step 7
Signed
SummaryCRS Summary
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 bef...
Timeline · 4 actions
Apr 7, 2023
Referred to the Subcommittee on Health.
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.
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.