Medical Innovation Acceleration Act of 2025

The Medical Innovation Acceleration Act of 2025 aims to amend the Federal Food, Drug, and Cosmetic Act, specifically targeting the regulation of certain diagnostic tools. Its core provision is to exempt non-invasive diagnostic devices from regulation as medical devices under Section 201(h) of the Act. The bill precisely defines "non-invasive" for these devices, requiring that they do not penetrate the skin or any other body membrane, nor are they inserted or implanted. Additionally, such devices must cause only ephemeral compression or temperature changes to bodily tissues and must not subject these tissues to ionizing radiation, thereby creating a distinct category for less intrusive diagnostic technologies.