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FDA finalises guidance on clinical decision support software

Published by Isabella Greenock, Medical Device Paralegal on

The FDA has issued its long awaited final guidance outlining how it intends to interpret the Federal Food, Drug and Cosmetic (the FD&C Act) in relation to clinical decision support (CDS) software.

CDS software can be broadly defined as software that provides healthcare professionals and patients with targeted information for the purpose of enhancing healthcare delivery. It encompasses a variety of tools such as computerised alerts/reminders, clinical guidelines, condition-specific order sets, focused patient data reports, documentation templates, diagnostic support and contextually relevant reference information.[1]

The FDA’s guidance centres around s.520(o) of the FD&C Act which excludes CDS software from the definition of a medical device providing the following four criteria are met: 

  • The CDS is not intended to acquire, process or analyse medical device images, signals from IVDs or signals/patterns from signal acquisition systems,
  • The CDS is intended to display, analyse or print medical information about the patient/other medical information, 
  • The CDS is intended to support or provide recommendations to healthcare professionals about the prevention, diagnosis or treatment of a disease/condition, and 
  • The CDS enables healthcare professionals to independently review the basis for its recommendations.

The guidance sets out the FDA’s interpretation of the above criteria, elaborating on the meaning of terms such as “medical information about the patient” and “other medical information”, as well as providing a useful list of examples of regulated/unregulated CDS software. 

However, publication of the guidance has led to concerns from industry experts that the FDA is seeking to broaden the range of software it plans to regulate as medical devices. In particular, the assertion that software providing specific diagnostic/treatment output or supporting time-critical decision making would fail the above criteria (on the grounds that the intention is to direct healthcare professionals to take a specific action and act as a substitute for their judgement) has been seen as an attempt to place further conditions on the software’s communication of its recommendations that does not reflect the language of the FD&C Act.[2]

If you are interested in finding out whether this updated guidance changes the regulation of your device, please register your interest in our AI-powered guide to the medical device regulations (below). Our guided assessment incorporates all official updates to the regulations and can help you navigate the complicated regulatory maze.

 

[1] FDA, FDASIA Health IT Report (April 2014)

[2] See RAPS: Regulatory Focus, Legal expert: FDA’s CDS software guidance is a ‘disaster’ for industry (quoting Bradley Merrill Thompson, medical device attorney at Epstein Becker & Green)