Us Congress Senate Bill SJR82

Us Congress 2023-2024 Regular Session

• Introduced: 5/15/24
• Refer: 5/15/24

Caption

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".

Impact

If passed, SJR82 would effectively rescind the FDA's rule on Medical Devices and Laboratory Developed Tests, which may have significant implications for the regulation of these technologies at the federal level. The current rule, which is designed to streamline processes for developing and approving certain medical devices, could face review or alteration. This disapproval indicates a shift in regulatory oversight and could lead to further legislative actions addressing how medical devices are evaluated and approved in the future.

Summary

SJR82 is a joint resolution aimed at providing congressional disapproval of a rule put forth by the Food and Drug Administration (FDA) concerning Medical Devices and Laboratory Developed Tests. This resolution critiques the existing rule, emphasizing the need for additional oversight from Congress concerning regulations that govern medical technologies. The joint resolution serves as a formal process under Chapter 8 of Title 5 of the United States Code, allowing Congress to disapprove regulations deemed unfit or requiring reconsideration.

Contention

Notable points of contention surrounding SJR82 include concerns about the balance of regulatory authority between Congress and the FDA. Proponents of the resolution argue that Congress must assert its oversight over crucial healthcare regulations to enhance accountability and ensure patient safety. Critics, however, may see this move as an unnecessary intervention that could slow down the approval of innovative medical technologies, which could negatively impact public health and access to new treatments.