On September 27, 2022, FDA announced the publication of a  final guidance  document entitled Clinical Decision Support Software, Guidance for Industry and Food and Drug Administration Staff (Final CDS Guidance), which focuses on clarifying the types of clinical decision support (CDS) software functions that are excluded from the definition of device by the criteria in section 520(o)(1)(E) of the Federal Food Drug and Cosmetic Act.

This final guidance document addresses industry comments made in response to FDA’s September 2019 draft guidance (Draft CDS Guidance). The Final CDS Guidance streamlines the Draft CDS Guidance by focusing the scope on CDS intended to be used by state licensed, registered, or certified health care professionals , rather than those also used by patients and caregivers, which were included in the scope of the Draft CDS Guidance.

Final guidance differs from draft guidance

Additionally, the Draft CDS Guidance’s detailed discussion and application of the International Medical Device Regulators Forum final document entitled ‘‘Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations” is absent from the Final Guidance. 

The Final Guidance also contains clearer organization and examples to identify FDA’s views on non-device CDS software functions and device software functions.

Patients and caregivers subject to other guidance

Please note FDA also states that CDS intended for caregivers or patients continue to be subject to FDA’s other guidance documents, which include:

  • Policy for Device Software Functions and Mobile Medical Applications,
  • Software as a Medical Device (SaMD): Clinical Evaluation,
  • Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices, and
  • General Wellness: Policy for Low Risk Devices. 

Copies of these documents can be found here on FDA’s website.

As such, we recommend anyone who has relied upon the Draft CDS Guidance to review the updates in the Final CDS Guidance and asses where they fall within FDA’s current thinking on this issue.  

Reed Smith will continue to monitor developments in FDA guidance. For any questions on the Final Guidance or FDA issues, please contact the authors of this post or your health care attorney at Reed Smith.