Draft Guidance on Clinical and Patient Decision Support Software

The Federal Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) is now accepting comments on its December 8, 2017 Draft Guidance for Industry and Food and Drug Administration Staff on Clinical and Patient Decision Support Software (CDS and PDS).1 The draft guidance was issued in response to the 21st Century Cures Act’s amended definition of a medical device.

The revised definition of a medical device reflects new and expanding technologies in the healthcare marketplace. The FDA is seeking specifically to clarify its interpretation of what constitutes decision support software, as well as its intended regulatory oversight. The FDA also is clearly defining PDS software as software intended for use by patients or caregivers or other non-healthcare professionals. By clarifying the definitions, the FDA can delineate recommendations for its role in regulatory oversight.

The overarching theme of the guidance is that devices that simply gather publicly available recommendations and present them to a person based on established patient characteristics or drug profiles will not be deemed medical devices. In those circumstances, patients could independently find all the information on their own.

The FDA uses the Cures Act’s first three criteria to define decision support software and differentiate it from a device:

  • Not intended to acquire, process or analyze a medical image or signal from an in vitro diagnostic device or a pattern or a signal from a signal acquisition system;
  • 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); and
  • Intended for the purpose of supporting or providing recommendations to a healthcare professional about prevention, diagnosis and treatment of a disease or condition.

It then adds a fourth criterion to exclude certain software from meeting the definition of a device:

  • 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 such recommendation to make a clinical diagnosis or treatment decision regarding an individual patient.

This added criterion establishes the function of software allowing independent clinician review. The FDA specifically carved out PDS to exclude it from FDA-intended regulatory oversight regarding premarket clearance and/or approval. The guidance draft document provides examples of software functions that will remain under FDA regulatory purview.

The FDA is accepting comments and suggestions regarding this draft guidance document for 60 days post-publication. Once finalized, the FDA recommendations will be incorporated into other FDA guidance documents.

Draft Guidance for SAMD

In a second document also released on December 8, 2017, the FDA provides finalized guidance for software as a medical device (SAMD) for clinical evaluation.2 The document reflects a standardized approach to terminology, a risk categorization framework and a process for evaluating SAMD devices. The guidance aligns with the International Medical Device Forum (IMDF). It precedes FDA publication of regulatory approaches to SAMD devices for public comment.

Conclusion

As healthcare vendors seek greater interoperability with existing platforms and work to gain and grow international market share, it is to their benefit to carefully review both documents within the framework of their existing products. This is the time to give important feedback and suggestions to the FDA that ultimately will impact final regulations.