Medical Innovation Acceleration Act of 2025
Medical Innovation Acceleration Act of 2025
Plain Language Summary
# Medical Innovation Acceleration Act of 2025 - Summary **What the Bill Would Do** This bill would remove certain diagnostic devices from FDA (Food and Drug Administration) oversight. Specifically, it would exempt "noninvasive diagnostic devices"—tools that diagnose health conditions without breaking the skin or entering the body—from FDA regulatory requirements. Examples would include devices that use compression, temperature changes, or other non-invasive methods to detect medical conditions. The bill does not affect devices that use radiation, penetrate skin, or are implanted in the body. **Who It Affects and Key Details** The bill primarily affects manufacturers of diagnostic devices and patients who use them.
By removing FDA oversight, companies could theoretically bring these devices to market faster and with fewer regulatory hurdles. However, this also means less government review for safety and effectiveness before they reach consumers. The bill is currently in committee, meaning it hasn't advanced to a full House vote yet. **Current Status** HR 88 was introduced in the 119th Congress by Representative Andy Biggs (R-AZ) and remains in committee review as of this summary.
CRS Official Summary
Medical Innovation Acceleration Act of 2025This bill exempts noninvasive diagnostic devices from the regulatory authority of the Food and Drug Administration.The bill defines noninvasive diagnostic device as one that does not penetrate the skin or any other membrane of the body, is not inserted or implanted into the body, causes no more than ephemeral compression or temperature changes to in situ bodily tissues, and does not subject bodily tissues to ionizing radiation.
Latest Action
Referred to the House Committee on Energy and Commerce.