H.R. 88 — Medical Innovation Acceleration Act of 2025

This section amends the definition of “device” under the Federal Food, Drug, and Cosmetic Act to exclude any non-invasive diagnostic device in addition to the matters described in section 520(o) (i.e., certain software functions). For these purposes, “non-invasive” means the device does not penetrate the skin or any other body membrane, is not inserted or implanted into the body, causes no more than ephemeral compression or temperature changes to bodily tissues, and does not subject bodily tissues to ionizing radiation. (Thus, qualifying devices are exempt from regulation as medical devices.)