Bill > HR88

This bill amends the Federal Food, Drug, and Cosmetic Act to create a new exemption for non-invasive diagnostic devices from certain regulatory requirements. Specifically, the bill defines "non-invasive" as a diagnostic device that does not penetrate the skin or body membranes, is not inserted or implanted, causes only temporary compression or temperature changes to bodily tissues, and does not expose tissues to ionizing radiation. By adding this definition and exemption to Section 201(h) of the existing law, the bill aims to reduce regulatory burdens on medical diagnostic technologies that do not physically interact with or significantly impact the body. The legislation, named the "Medical Innovation Acceleration Act of 2025", appears designed to streamline the regulatory process for developing and bringing to market less intrusive medical diagnostic tools, potentially encouraging medical innovation by reducing administrative obstacles for such devices.

Business and Industry

https://www.congress.gov/bill/119th-congress/house-bill/88/all-info