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FDA Clinical Decision Support (CDS) Software Guidance & Regulatory Demarcation

Navigating Section 520(o)(1)(E) criteria, Software as a Medical Device (SaMD) exemption, and physician autonomy.

Executive Overview

The FDA Clinical Decision Support (CDS) Software Guidance clarifies which algorithmic software functions are excluded from FDA medical device regulation under the 21st Century Cures Act, and which AI/ML diagnostic tools remain actively regulated medical devices.

1. The Four Non-Device CDS Statutory Criteria

To be excluded from FDA medical device regulation under Section 520(o)(1)(E), software must meet ALL four criteria:

  1. It is NOT intended to acquire, process, or analyze medical images or signals (ECG, EEG).
  2. It is intended to display, analyze, or print medical information (EHR records, peer-reviewed clinical guidelines).
  3. It is intended to support or provide recommendations to a Healthcare Professional (HCP) about prevention, diagnosis, or treatment.
  4. It enables the HCP to independently review the basis for the recommendation so they do not rely primarily on the software.

Frequently Asked Questions

Can an AI model that outputs an unexplainable 'black-box' risk score qualify as non-device CDS?

No. If the physician cannot inspect the underlying clinical logic, features, and patient data driving the recommendation (violating Criterion 4), the software is classified as a regulated Medical Device requiring FDA clearance.

AI Summary

The FDA Clinical Decision Support (CDS) Software Guidance clarifies which algorithmic software functions are excluded from FDA medical device regulation under the 21st Century Cures Act, and which AI/ML diagnostic tools remain actively regulated medical devices.