Medical Innovation Acceleration Act of 2025
1/31/2025, 3:38 AMSummary of Bill HR 88
Bill 119 HR 88, also known as the Non-Invasive Diagnostic Device Regulation Act, aims to make changes to the Federal Food, Drug, and Cosmetic Act in order to exempt certain non-invasive diagnostic devices from regulation as medical devices. The bill seeks to streamline the regulatory process for these types of devices, which are used for diagnostic purposes without penetrating the skin or body cavities.The main purpose of this bill is to promote innovation and access to non-invasive diagnostic devices by reducing regulatory burdens on manufacturers. By exempting these devices from certain regulations, the bill aims to encourage the development of new technologies that can improve healthcare outcomes and patient care.
In addition to exempting non-invasive diagnostic devices from regulation, the bill also includes provisions for other purposes related to the regulation of medical devices. These provisions are aimed at ensuring the safety and effectiveness of medical devices while also promoting innovation and access to new technologies. Overall, Bill 119 HR 88 is focused on promoting innovation in the field of non-invasive diagnostic devices and improving access to these technologies for healthcare providers and patients. The bill aims to strike a balance between ensuring the safety and effectiveness of medical devices and reducing regulatory burdens that may hinder innovation in this important area of healthcare.
Congressional Summary of HR 88
Medical Innovation Acceleration Act of 2025
This 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.
Read the Full Bill
Current Status of Bill HR 88
Bill HR 88 is currently in the status of Bill Introduced since January 3, 2025. Bill HR 88 was introduced during Congress 119 and was introduced to the House on January 3, 2025. Bill HR 88's most recent activity was Referred to the House Committee on Energy and Commerce. as of January 3, 2025Bipartisan Support of Bill HR 88
Total Number of Sponsors
6Democrat Sponsors
0Republican Sponsors
6Unaffiliated Sponsors
0Total Number of Cosponsors
0Democrat Cosponsors
0Republican Cosponsors
0Unaffiliated Cosponsors
0Policy Area and Potential Impact of Bill HR 88
Primary Policy Focus
Alternate Title(s) of Bill HR 88
To amend the Federal Food, Drug, and Cosmetic Act to exempt from regulation as devices non-invasive diagnostic devices, and for other purposes.To amend the Federal Food, Drug, and Cosmetic Act to exempt from regulation as devices non-invasive diagnostic devices, and for other purposes.Comments
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Sponsors and Cosponsors of HR 88
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