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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.
3/22/2025, 8:06 AM
Summary of Bill HR 1463
The FDA's final rule on laboratory developed tests has been a topic of debate, with some arguing that it could hinder innovation and access to important medical tests. This bill aims to address these concerns by preventing the use of Federal funds to enforce the rule.
In addition to prohibiting the use of Federal funds for this specific FDA rule, the bill also includes provisions for other purposes related to medical devices and laboratory developed tests. The exact details of these additional purposes are not specified in the bill text. Overall, Bill 119 HR 1463 seeks to limit the FDA's authority in regulating laboratory developed tests and medical devices by restricting the use of Federal funds for enforcement of a specific rule. The bill reflects ongoing discussions and disagreements surrounding FDA regulations and their impact on medical innovation and access to healthcare services.
Congressional Summary of HR 1463
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.
Current Status of Bill HR 1463
Bipartisan Support of Bill HR 1463
Total Number of Sponsors
7Democrat Sponsors
0Republican Sponsors
7Unaffiliated Sponsors
0Total Number of Cosponsors
8Democrat Cosponsors
0Republican Cosponsors
8Unaffiliated Cosponsors
0Policy Area and Potential Impact of Bill HR 1463
Primary Policy Focus
HealthAlternate Title(s) of Bill HR 1463
Comments
Donald Currin
9 months ago
This bill is ridiculous. Who does it really help?
Paul Crane
8 months ago
I believe that this bill could have negative consequences for the safety and effectiveness of medical devices and laboratory developed tests. It is important for the FDA to have the resources to regulate these products to ensure they meet necessary standards. As a consumer, I want to have confidence in the medical devices and tests that I use, and this bill could potentially compromise that.
