Us Congress House Bill HJR145

Us Congress 2023-2024 Regular Session

• Introduced: 5/16/24
• Refer: 5/16/24
• Refer: 5/24/24

Caption

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

Should HJR145 be enacted, it would significant impact regulations concerning medical devices and laboratory tests at the federal level. The resolution reflects ongoing tensions between Congress and regulatory agencies like the FDA, particularly regarding the balance of power and the ability of agencies to implement rules that affect healthcare practices and product approvals. Disapproval of the rule could lead to a recalibration of standards and expectations in the medical device market.

Summary

HJR145 is a joint resolution aimed at disapproving a rule submitted by the Food and Drug Administration (FDA) concerning Medical Devices and Laboratory Developed Tests. The rule in question was published in the Federal Register and is viewed by the proponents of the resolution as an overreach of FDA authority. HJR145 seeks to invalidate the rule entirely, ensuring it will have no force or effect should the resolution pass.

Contention

The discussion surrounding HJR145 is likely to involve varying opinions on the role of the FDA and the implications of congressional disapproval of regulatory actions. Supporters of HJR145 argue that the FDA's rule may impose unnecessary burdens or could hinder innovation in the medical sector, while opponents might express concerns that disallowing such regulations could compromise the safety and efficacy of medical devices and tests available to the public. The resolution has the potential to spark debates about regulatory oversight and the legislative branch's role in healthcare matters.