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Congress blocks strict FDA oversight of laboratory developed diagnostic tests.

This resolution aims to nullify a new Food and Drug Administration (FDA) rule that would have imposed strict federal oversight on specialized diagnostic tests developed within laboratories (LDTs). If the resolution passes, these tests will remain exempt from the new, rigorous federal requirements. This means the availability and costs of many personalized diagnostic tests will not be immediately affected by the new FDA regulations.
Key points
Halting FDA plans to treat Laboratory Developed Tests (LDTs) as traditional medical devices subject to strict control.
Diagnostic tests developed by laboratories (e.g., personalized genetic testing) will remain outside new, strict federal regulations for now, potentially impacting their availability and innovation.
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Additional Information
Print number: 118_SJRES_82
Sponsor: Sen. Paul, Rand [R-KY]
Process start date: 2024-05-15
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Summarized by: gemini-2.5-flash-preview-09-2025
Source data: api.congress.gov
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OFFICIAL LEGAL TITLE

A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Food and Drug Administration relating to "Medical Devices; Laboratory Developed Tests".

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 118_SJRES_82.

Which chamber initiated this legislation?

This legislation was initiated in the Senate.

When did the legislative process begin?

The process officially started on 2024-05-15.

What are the main provisions?

Key points include:

  • Halting FDA plans to treat Laboratory Developed Tests (LDTs) as traditional medical devices subject to strict control.
  • Diagnostic tests developed by laboratories (e.g., personalized genetic testing) will remain outside new, strict federal regulations for now, potentially impacting their availability and innovation.
What is the specific legal status?

The current status is Expired.

Where can I read the full text of this legislation?

The full official text is available at: View full text

Who is the primary sponsor?

The primary sponsor is Sen. Paul, Rand [R-KY].

What is the latest detailed status?

The latest detailed status is: Introduced in Senate

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2025-12-26.

CATEGORIES

Health