FDA loses oversight of diagnostic devices in new 'innovation' bill
H.R. 88 — Medical Innovation Acceleration Act of 2025 · Filed by Andy Biggs (R-AZ) · Introduced Jan 3, 2025 · Referred to committee
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What it does
This bill amends federal drug and device law to exempt non-invasive diagnostic devices—those that do not penetrate skin, are not implanted, cause only temporary compression or temperature changes, and do not use ionizing radiation—from FDA regulation as medical devices. The exemption removes these devices from the pre-market approval and post-market oversight requirements that currently apply to diagnostic devices, allowing manufacturers to bring them to market without FDA clearance.
Why we flagged it
The bill's operative mechanism is a categorical exemption from FDA device regulation. Despite the 'innovation acceleration' framing, the core function is to remove pre-market safety review and post-market oversight for a class of diagnostic devices, shifting regulatory burden from manufacturers to end-users.
What the text implies
- The definition of 'non-invasive' excludes ionizing radiation but does not exclude other forms of radiation (microwave, RF, ultrasound), potentially allowing unvetted electromagnetic diagnostic devices to market.
- Diagnostic devices exempt from FDA oversight may still make medical claims (e.g., 'detects disease X') without evidence of accuracy, creating a market for unvalidated diagnostics that could delay treatment or cause patient harm.
The full analysis lists 5 implications of this text.
Who stands to gain
diagnostic device manufacturers; wearable technology companies; at-home testing kit producers