The civic record
Read. Follow. Verify.Proposed Resolution to Block FDA Regulation of Laboratory-Developed Tests
Record date · May 24, 2024
Track this bill to get notified when it advances a stage. One tap to stop, anytime.
What This Bill Would Do
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.
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 It Would Affect
Groups the bill's text would affect if enacted, as described in the record. Being affected is not a position for or against it.
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.
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.
Frequently Asked Questions
What is a laboratory-developed test (LDT)?
What does this resolution do?
What else do you want to know?
News Coverage
Follow the record
Votes, people, money & the original sourceWhere This Stands
Currently filed. The next step in the legislative lifecycle is Committee.
Version history
Only one version on file - nothing to compare yet. As later stages (committee substitute, engrossed, enrolled) are captured, the redline appears here.
View official text →Full breakdown
Who this bill affects and the strongest case for and against it, written only from the bill’s own text.
Discoveries
Patterns POLISCOPE noticed across the record. These are observations to investigate, not conclusions.
Congressional Oversight of FDA Rulemaking
The resolution demonstrates the use of the Congressional Review Act to challenge specific agency rulemaking regarding medical device classification.
Connected Entities
Sources
www.congress.gov
Analysis Score
0–100- Significance85How much this matters to a regular citizen
- Controversy75Intensity of disagreement among stakeholders
- Entertainment10Compellingness for a non-policy-wonk reader
- Buzz40Current news / social attention level
Publisher tools