H.R. 1463: 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.

This bill aims to prevent Federal funds from being used to support a specific rule made by the Food and Drug Administration (FDA) regarding medical devices and laboratory developed tests. The key aspects of the bill are as follows:

Prohibition on Federal Funding

The legislation specifically prohibits the use of any Federal financial resources to:

• Implement the rule that the FDA created on medical devices and laboratory developed tests, which was published in the Federal Register on May 6, 2024.
• Administer the rule and its procedures.
• Enforce the rule that pertains to these medical devices and tests.

Scope of the Rule

The veterinary devices and laboratory developed tests in question typically include items that are created or modified for medical purposes outside of traditional mass-produced medical devices. The FDA's rule was intended to set guidelines for how these should be evaluated for safety and effectiveness.

Impact of the Bill

If this bill passes, the rule that was intended to regulate laboratory developed tests and certain medical devices would not be enforced by the federal government. This can have implications on how these tests and devices are marketed, validated, and monitored for public safety.

Overall Objective

The bill reflects legislative efforts to influence regulatory oversight specifically related to the medical device and diagnostic testing industry, signaling a shift in how the government intends to interact with these products and their developers.

Relevant Companies

• ILMN - Illumina, Inc.: A company specializing in genomic sequencing, potentially affected by changes in the regulation of laboratory developed tests.
• MDXG - MiMedx Group, Inc.: A producer of regenerative medicine products, which may be impacted by FDA regulations.