US Federal 2025-2026 Regular Session

US Federal House Bill HB88

Introduced
1/3/25  

Caption

Medical Innovation Acceleration Act of 2025This bill exempts noninvasive diagnostic devices from the regulatory authority of the Food and Drug Administration.The bill defines noninvasive diagnostic device as one that does not penetrate the skin or any other membrane of the body, is not inserted or implanted into the body, causes no more than ephemeral compression or temperature changes to in situ bodily tissues, and does not subject bodily tissues to ionizing radiation.

Impact

If passed, HB88 would significantly alter the landscape of medical device regulation in the United States. Supporters of the bill argue that it will accelerate the development and availability of cutting-edge diagnostic technologies, which could lead to improved patient outcomes and lower healthcare costs. By lessening the regulatory burden on developers and manufacturers of non-invasive devices, the bill could stimulate investment in healthcare innovation. This change could also enhance access to essential diagnostic tools, especially in underserved communities where traditional diagnostic methods may be less available.

Summary

House Bill 88, known as the Medical Innovation Acceleration Act of 2025, aims to amend the Federal Food, Drug, and Cosmetic Act. The primary objective of this legislation is to exempt non-invasive diagnostic devices from being categorized as medical devices under existing regulations. By clarifying the definition of non-invasive devices—those that do not penetrate the skin or subject bodily tissues to ionizing radiation—the bill seeks to promote innovation in the medical technology sector. This type of diagnostic device often includes methods such as imaging or sound waves that assess patient health without physical intrusion.

Contention

Despite the potential benefits, there are concerns regarding patient safety and the potential for increased risks associated with less regulatory oversight. Critics fear that exempting these devices from traditional regulation could lead to the introduction of ineffective or unsafe products into the marketplace. Advocacy groups and some healthcare professionals emphasize the importance of stringent testing and monitoring of medical devices to ensure they meet safety standards. The debate over HB88 reflects broader tensions in the healthcare industry between fostering innovation and maintaining patient safety standards.

Congress_id

119-HR-88

Introduced_date

2025-01-03

Companion Bills

No companion bills found.

Previously Filed As

US HB95

One Bill, One Subject Transparency ActThis bill prohibits any bill or joint resolution from addressing more than one subject and establishes related enforcement mechanisms.The bill requires bills and joint resolutions to address only one subject, which must be clearly and descriptively expressed in the bill or joint resolution's title. Appropriations bills may only contain provisions that are germane to the subject matter of the underlying bill. However, appropriations bills may limit the expenditure of appropriated funds.The bill voids any act (i.e., law) or joint resolution with a title that addresses two or more unrelated subjects;any provision of an act or joint resolution concerning a subject that is not clearly and descriptively expressed in the title;any provision of an appropriations act that contains general legislation or change of existing law provision not germane to the subject matter of the underlying bill;any provision of an appropriations act that addresses a subject outside of the jurisdiction of the relevant subcommittee of the Committees on Appropriations of the House and of the Senate.The bill also authorizes any person aggrieved by the enforcement or threat of enforcement of an act enacted after this bill that does not comply with the requirements of this bill to sue the United States.

US HB456

Protecting Dogs Subjected to Experiments Act This bill prohibits the National Institutes of Health from funding biological, medical, or behavioral research that involves testing dogs.

US HB1108

Diagnostics Testing Preparedness Plan Act of 2025

US HB06080

An Act Concerning Medicaid Coverage Of Noninvasive, Custom Breast Prostheses For Mastectomy Patients.

US HB05139

An Act Concerning Registration Fees For Diagnostic And Therapeutic X-ray Devices .

US HB1059

Jobs and Opportunities for Medicaid Act This bill establishes work requirements under Medicaid for able-bodied adults. Specifically, the bill requires individuals who are between the ages of 18 and 65 and who are not otherwise unable to work due to a medical condition, family situation, or other listed reason to work or volunteer at least 20 hours per week, based on a monthly average, in order to qualify for Medicaid.

US SB207

Protecting Life on College Campus Act of 2025This bill prohibits the award of federal funds to an institution of higher education (IHE) that hosts or is affiliated with a school-based service site that provides abortion drugs or abortions to its students or to employees of the IHE or the site. An IHE that hosts or is affiliated with a site must, in order to remain eligible for federal funds, annually certify that the site does not provide abortion drugs or abortions to students or employees.

US HB340

The HCT/P Modernization Act of 2025This bill requires the Food and Drug Administration (FDA) to provide information to stakeholders and report on the regulation of human cell and tissue products, also referred to as human cells, tissues, or cellular or tissue-based products (HCT/Ps), which are articles containing or consisting of human cells or tissues that are intended for use in a human recipient.The bill requires the FDA to conduct workshops to educate stakeholders and facilitate discussion with them on advancing the science and regulation of human cell and tissue products. The FDA must establish a public docket to receive written comments on this topic, and submit to Congress a report with recommendations on regulating these products. Additionally, the bill requires the FDA to publish on its website educational materials about the Tissue Reference Group and best practices for obtaining a recommendation about products from them. Also, annually for three years, the FDA must publish on its website information on the inquiries submitted and average response times for the Tissue Reference Group, as well as the number of human cell and tissue manufacturers that have registered with the FDA and the number of inspections the FDA has conducted with respect to these manufacturers since 2019. (The Tissue Reference Group is a working group within the FDA that receives product-specific questions from, and provides recommendations for, stakeholders on the regulation of human cell and tissue products under the FDA’s rules.) 

US HB843

Prompt Approval of Safe Generic Drugs ActThis bill authorizes the Food and Drug Administration (FDA) to approve certain applications to market a generic drug despite the omission of certain safety information from the generic drug's labeling.Specifically, the FDA may not deem an abbreviated application for approval of a generic drug ineligible for approval solely because the drug's labeling omits safety information that is protected under another drug's patent or exclusivity protections. Similarly, a drug that is approved under this bill may not be considered mislabeled for lacking such safety information.Generally, an abbreviated application, for the purposes of this bill, is one that (1) uses required information from studies not conducted by the applicant; or (2) seeks approval of a drug that is, for drug approval purposes, a duplicate of an already-approved drug (i.e., a generic drug). Currently, the labeling for such a generic drug must generally be identical to that of the already-approved drug. This bill provides an exception to that requirement under the specified circumstances. For any drug approved under this bill, the FDA must require the drug's labeling to include any safety information that is necessary to assure safe use.

US SB447

Jobs and Opportunities for Medicaid Act This bill establishes work requirements under Medicaid for able-bodied adults. Specifically, the bill requires individuals who are between the ages of 18 and 65 and who are not otherwise unable to work due to a medical condition, family situation, or other listed reason to work or volunteer at least 20 hours per week, based on a monthly average, in order to qualify for Medicaid.

Similar Bills

No similar bills found.