Medical Innovation Acceleration Act of 2025
The Medical Innovation Acceleration Act of 2025 would change current U.S. law to exempt non-invasive diagnostic devices from regulation as medical devices under the Federal Food, Drug, and Cosmetic Act. Specifically, it adds non-invasive diagnostic devices to an existing exemption pathway (the 520(o) exemption), meaning these devices would face less regulatory oversight before reaching the market. The bill also codifies a precise definition of “non-invasive,” describing devices that do not penetrate skin or body membranes, are not inserted or implanted, cause only ephemeral (short-lived) changes to tissues, and do not expose tissues to ionizing radiation. The intent appears to be to speed up the development and deployment of diagnostic tools that do not physically enter the body, potentially lowering costs and time-to-market for innovators. In exchange, oversight would be reduced for these devices relative to traditional regulated medical devices. The practical impact would depend on how broadly the exemption is interpreted by regulators and how the non-invasive definition is applied in real-world device categories.
Key Points
- 1The bill is titled the Medical Innovation Acceleration Act of 2025 and was introduced in the House (H.R. 88) by Mr. Biggs of Arizona; it proposes a statutory change to the FDA’s device regulation framework.
- 2It expands the exemption from regulation as medical devices to include non-invasive diagnostic devices, adding “any non-invasive diagnostic device” to the existing exemption pathway found in section 520(o) of the FD&C Act.
- 3A specific definition of non-invasive is added: the device does not penetrate the skin or any body membrane, is not inserted or implanted, causes only ephemeral compression or temperature changes to in situ tissues, and does not expose tissues to ionizing radiation.
- 4The change is limited to non-invasive diagnostic devices; other devices and existing regulatory requirements outside the exemption remain governed by current law.
- 5The bill relies on a precise, narrow definition to determine what qualifies for exemption, aiming to accelerate innovation while clarifying the boundary for regulatory relief.