To amend the Federal Food, Drug, and Cosmetic Act to exempt from regulation as devices non-invasive diagnostic devices, 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 exempting non-invasive diagnostic devices from regulation as devices Section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. It relies on definition changes and exemptions. The main policy areas are Healthcare and Healthcare Consumers.
Who Benefits and How
Patients and health care consumers affected by the bill could face lower compliance burdens.
Who Bears the Burden and How
Public beneficiaries or protected communities affected by the clause could face increased risk.
Key Provisions
- Exempts exempting non-invasive diagnostic devices from regulation as devices Section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
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 exempting non-invasive diagnostic devices from regulation as devices Section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
Key Policy Areas
Healthcare, Healthcare Consumers
Primary Purpose
The bill exempts exempting non-invasive diagnostic devices from regulation as devices Section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
Policy Domains
Whole bill
Identified Gains
- Patients and health care consumers affected by the bill
Identified Costs
- Public beneficiaries or protected communities affected by the clause
Sponsors
Legislative Progress
IntroducedMr. Biggs introduced the following bill; which was referred to …
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?
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
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