Medical Innovation Acceleration Act of 2025

This bill would remove Food and Drug Administration (FDA) oversight from certain noninvasive diagnostic devices. In plain terms, tools that check your health from the outside—without breaking the skin, going inside the body, or using ionizing radiation—would no longer be regulated as “medical devices” by the FDA. The goal is to make it easier and faster to bring these kinds of tests and tools to the public.

A device would count as “noninvasive” if it:

• Does not penetrate the skin or any body membrane
• Is not inserted or implanted
• Causes only brief pressure or temperature changes on tissues
• Does not expose tissues to ionizing radiation

Key points:

• Who is affected: Patients, health care providers, and companies that make noninvasive diagnostic tools.
• What changes: These devices would be exempt from FDA regulation as medical devices, potentially speeding up availability and reducing compliance steps for manufacturers .
• When: The provided text does not specify timing or an effective date.