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FDA Finalizes Which Clinical Decision Software Functions it Regulates

The FDA has clarified the criteria for which clinical decision software it regulates as a medical device.

US FDA formally proposes aligning Quality System Regulations with ISO 13485

October 5, 2022

The US Food and Drug Administration (FDA) announced that it has finalized guidance on which clinical decision software (CDS) functions it regulates as a medical device.

The agency released its latest position in the Clinical Decision Support Software document. The guidance clarifies the criteria in section 520(o) of the FD&C Act for identifying CDS functions that are not regulated as medical devices, known as non-device CDS. Notably, a software function must meet all four criteria to be excluded from the device definition.

A CDS function must meet all of these criteria to be exempt from medical device regulations:

  • Not intended to acquire, process or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system (section 520(o)(1)(E)(i) of the FD&C Act)
  • Intended for the purpose of displaying, analyzing, or printing medical information about a patient or other medical information (such as peer-reviewed clinical studies and clinical practice guidelines) (section 520(o)(1)(E) of the FD&C Act)
  • Intended for the purpose of supporting or providing recommendations to a health care professional about prevention, diagnosis or treatment of a disease or condition (section 520(o)(1)(E)(ii) of the FD&C Act)
  • Intended for the purpose of enabling such healthcare professional to independently review the basis for such recommendations that such software presents so that it is not the intent that such healthcare professional rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient (section 520(o)(1)(E)(iii) of the FD&C Act)

The document includes examples of non-device CDS software functions as well as device software functions on which the FDA intends to focus its regulatory oversight.

Which clinical decision software does FDA consider a medical device?

The FDA has revised some of its documentation to reflect the final rule which removed certain software functions from the medical device regulations in accordance with the medical device software provisions of the 21st Century Cures Act.

FDA updated the following guidance documents to reflect the changes:

  • Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices
  • Policy for Device Software Functions and Mobile Medical Applications
  • Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions
  • Display Devices for Diagnostic Radiology
  • Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Notification [510(k)] Submissions

Emergo by UL will continue to post updates to FDA guidance as they become available.