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Prescribing AI

What is regulated as a device, and what is not

Medication decision support and imaging devices are not the same regulatory object. This page explains the statute and the FDA guidance, then reports what the public device list actually contains.

Section 3060(a) of the 21st Century Cures Act, which the FDA guidance page says was enacted on December 13, 2016, amended section 520 of the Federal Food, Drug, and Cosmetic Act. The exclusion for certain decision support software is codified at 21 U.S.C. 360j(o)(1)(E).

In the House text of that provision, software is outside the device definition only when it is not intended to acquire, process, or analyze a medical image, a signal from an in vitro diagnostic device, or a pattern or signal from a signal acquisition system, and it is intended for all three of these purposes:

  1. displaying, analyzing, or printing medical information about a patient or other medical information;
  2. supporting or providing recommendations to a health care professional about prevention, diagnosis, or treatment; and
  3. enabling that professional to independently review the basis for the recommendations so that the professional is not intended to rely primarily on them for an individual clinical decision.

The binding words are the statute and the FDA guidance, not this paraphrase. Software that analyzes an image or a physiological signal, or that does not let a professional review the basis for a recommendation, can remain a device. This page is not a determination about any product.

The FDA guidance landing page is titled Clinical Decision Support Software, Guidance for Industry and Food and Drug Administration Staff, and is dated January 2026. Docket FDA-2017-D-6569. Read the guidance page and the PDF linked from that page.

What the device list shows

Device names on this copy of the FDA list were checked for these words: insulin, medication, medicine, prescribing, prescription, antibiotic, anticoagulant, formulary, and pharmacy. The word dose was left out on purpose. On this retrieval it showed up in radiation-dose product names, which a reader can still find with the device search.

None of the 1,614 device names matched that medication-word list. That is a description of the file, not a claim that no medication software is regulated.

Counts for three lab-related lead panels on the same list:

Most rows are radiology and cardiovascular imaging or signal devices. A listing here means FDA included the submission on its AI-enabled device list. It does not mean the product writes a prescription.