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.
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Bill details
Summary
Introduced in House
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.
District impact notes
This bill prohibits federal funding for the FDA's regulation of laboratory developed tests as medical devices. • The regulation of laboratory developed tests could impact local healthcare providers and their ability to offer certain diagnostic services. • Local laboratories that develop tests may face changes in how they operate under federal oversight, potentially affecting their services. • There may be questions about how the lack of federal funding could influence the FDA's ability to ensure the safety and effectiveness of these tests. AI-generated from official bill summary and plain-English note; verify with official text.
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