To prohibit the use of Federal funds to implement, administer, or enforce a final rule of the Food and Drug Administration relating to "Medical Devices; Laboratory Developed Tests", and for other purposes.
- Last Action
- 2/21/2025
Actions
- 2025-02-21Referred to the House Committee on Energy and Commerce.
- 2025-02-21Introduced in House
- 2025-02-21Introduced in House
CRS Summary
As of 2025-02-21 (00)
This bill prohibits the use of federal funds to implement, administer, or enforce the final rule issued by the Food and Drug Administration (FDA) titled Medical Devices; Laboratory Developed Tests and published on May 6, 2024, or any substantially similar rule.
The rule specifies that laboratory developed tests (medical screening tests developed by laboratories rather than medical device manufacturers) are medical devices subject to FDA regulation with limited exceptions. Prior to the rule, the FDA had exercised discretion as to whether to apply regulations for medical devices to laboratory developed tests.
Cosponsors (7)
- Dan Crenshaw (R-TX)
- Mariannette Miller-Meeks (R-IA)
- Randy Weber (R-TX)
- August Pfluger (R-TX)
- Neal Dunn (R-FL)
- Andy Barr (R-KY)
- Craig Goldman (R-TX)
Subjects
- Administrative law and regulatory procedures
- Drug safety, medical device, and laboratory regulation
- Food and Drug Administration (FDA)
- Health programs administration and funding
- Medical tests and diagnostic methods
Sourced from Congress.gov (public domain).
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