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HJRES145FEDERALIN_COMMITTEE
High Impact

Proposed Resolution to Block FDA Regulation of Laboratory-Developed Tests

Original title: HJRES 145: Congressional Disapproval of FDA Rule on Medical Devices and Laboratory Tests

May 24, 2024

healthcaremedical devicesFDAlaboratory testingfederal regulation

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Where This Stands

Introduced
Committee
Floor Vote
Passed

Currently IN_COMMITTEE. The next step in the legislative lifecycle is Floor Vote.

Version history

Only one version on file - nothing to compare yet. As later stages (committee substitute, engrossed, enrolled) are captured, the redline appears here.

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The Frame

What this does

The resolution directly impacts the regulatory framework for diagnostic testing, determining whether laboratories must comply with FDA medical device standards or continue operating under existing clinical laboratory oversight.

Who is mentioned in the record

Potentially affected actors named in the source documents. Mention is not a position.

Clinical laboratories

These entities would be subject to FDA medical device regulations if the rule remains in effect, or exempt from them if the resolution passes.

Food and Drug Administration

The agency's authority to regulate laboratory-developed tests as medical devices would be revoked by this resolution.

What changed

Current stage: IN_COMMITTEE.

What's next

Floor Vote.

Summary

This resolution seeks to overturn a recent FDA rule that classifies laboratory-developed tests (LDTs) as medical devices, which would effectively nullify the new federal oversight requirements. If passed, the FDA's May 2024 rule would be rendered void and unenforceable.

Key Facts

You don't have to trust us. Each fact below is taken straight from the official document - click any one to see the exact passage, highlighted in the original.

Why It Matters

The resolution directly impacts the regulatory framework for diagnostic testing, determining whether laboratories must comply with FDA medical device standards or continue operating under existing clinical laboratory oversight.

Frequently Asked Questions

What is a laboratory-developed test (LDT)?
An LDT is a type of diagnostic test that is designed, manufactured, and used within a single laboratory.
What does this resolution do?
It uses the to formally disapprove of a specific FDA rule, which would prevent the rule from being implemented or enforced.

News Coverage

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Discoveries

Patterns POLISCOPE noticed across the record. These are observations to investigate, not conclusions.

policy shift90% confidence

Congressional Oversight of FDA Rulemaking

The resolution demonstrates the use of the Congressional Review Act to challenge specific agency rulemaking regarding medical device classification.

Food and Drug AdministrationBrad Finstad

Connected Entities

otherchapter 8 of title 5“Specific section of the U.S. Code”Map →
organizationFood and Drug Administration“Agency responsible for issuing the rule”Map →
otherMedical Devices; Laboratory Developed Tests“Subject of the FDA rule”Map →
otherUnited States Code“Legal code governing the U.S. government”Map →

Analysis Score

0–100
  • Significance85
    How much this matters to a regular citizen
  • Controversy75
    Intensity of disagreement among stakeholders
  • Entertainment10
    Compellingness for a non-policy-wonk reader
  • Buzz40
    Current news / social attention level

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