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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
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".
Print number: SJRES 82
Sponsor: Sen. Paul, Rand [R-KY]
Process start date: 2024-05-15