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.

# Summary of HR 1463 **What the Bill Does:** This bill would block the federal government from spending money to enforce a new FDA rule that regulates laboratory-developed tests (LDTs)—medical tests created and used by individual laboratories rather than manufactured by device companies. The FDA issued this rule in May 2024 to treat these tests as medical devices subject to FDA oversight. This bill would essentially stop that regulation from being implemented. **Who It Affects:** The bill primarily impacts laboratories that develop and offer medical tests, as well as patients and healthcare providers who use these tests. Under the new FDA rule, labs would face stricter requirements for their tests.

This bill would prevent those requirements from taking effect, allowing labs to continue operating under the previous system where the FDA had more discretion about whether to regulate LDTs. **Current Status and Key Details:** HR 1463, introduced by Rep. Brad Finstad (R-Minnesota), is currently in committee and has not been voted on. Supporters argue the rule creates unnecessary burdens on labs, while opponents contend that FDA oversight helps ensure test accuracy and patient safety. The bill represents an ongoing debate about how much the FDA should regulate medical tests developed by laboratories.