To amend the Federal Food, Drug, and Cosmetic Act with respect to in vitro clinical tests, and for other purposes.
Analysis under review: This bill has generated analysis that may be too generic or incomplete. Clause-level evidence remains available below.
Summary
What This Bill Does
The bill exempts definitions Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C, creates regulation of in vitro clinical tests The Federal Food, Drug, and Cosmetic Act (21 U.S.C, and provides definitions In this subchapter: The term analytical validity means, with respect to an in vitro clinical test, the ability of the in vitro clinical test, to identify, measure, detect, calculate, or analyze (. It relies on compliance mandates, reporting requirements, appropriations, and definition changes. The main policy areas are Healthcare Consumers, Healthcare, Finance, and Environment.
Who Benefits and How
Patients and health care consumers affected by the bill could face lower compliance burdens, Environmental and public health interests affected by the bill could face lower compliance burdens, and Businesses and employers affected by the bill could gain revenue opportunities.
Who Bears the Burden and How
Federal, state, or local agencies responsible for implementing the clause would take on compliance duties, Patients and health care consumers affected by the bill could lose revenue opportunities, and Businesses and employers affected by the bill could lose revenue opportunities.
Key Provisions
- Exempts definitions Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
- Creates regulation of in vitro clinical tests The Federal Food, Drug, and Cosmetic Act (21 U.S.C.
- Provides definitions In this subchapter: The term analytical validity means, with respect to an in vitro clinical test, the ability of the in vitro clinical test, to identify, measure, detect, calculate, or analyze (...
- Requires regulation of in vitro clinical tests No person shall introduce or deliver for introduction into interstate commerce any in vitro clinical test, unless— an approval of an application filed pursuant...
- Provides premarket review Any developer may file with the Secretary an application for premarket approval of an in vitro clinical test under this subsection.
Evidence Chain:
This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers with clause-level evidence links.
At a Glance
What This Bill Does
The bill exempts definitions Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C, creates regulation of in vitro clinical tests The Federal Food, Drug, and Cosmetic Act (21 U.S.C, and provides definitions In this subchapter: The term analytical validity means, with respect to an in vitro clinical test, the ability of the in vitro clinical test, to identify, measure, detect, calculate, or analyze (.
Key Policy Areas
Healthcare Consumers, Healthcare, Finance, Environment
Primary Purpose
The bill exempts definitions Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C, creates regulation of in vitro clinical tests The Federal Food, Drug, and Cosmetic Act (21 U.S.C, and provides definitions In this subchapter: The term analytical validity means, with respect to an in vitro clinical test, the ability of the in vitro clinical test, to identify, measure, detect, calculate, or analyze (.
Policy Domains
Whole bill
Identified Gains
- Patients and health care consumers affected by the bill
- Environmental and public health interests affected by the bill
- Businesses and employers affected by the bill
- Homeowners, tenants, or housing market participants affected by the bill
- Financial services firms and customers affected by the bill
Identified Costs
- Federal, state, or local agencies responsible for implementing the clause
- Patients and health care consumers affected by the bill
- Businesses and employers affected by the bill
- Environmental and public health interests affected by the bill
- Researchers and scientific institutions affected by the bill
Sponsors
Legislative Progress
IntroducedMr. Bucshon (for himself and Ms. DeGette) introduced the following …
Impact analysis is available but no clear stakeholder effects identified. View clause-level analysis →
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
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