The Food and Drug Administration (FDA)’s draft guidance titled Clinical Decision Support Software provides details about when and under what regulatory frameworks the FDA intends to regulate the use of clinical decision support (CDS) software functions. The guidance does not specifically explain how FDA would regulate CDS software functions, but instead aims to delineate which sorts of CDS software functions would receive which types of FDA regulation.
The guidance first specifies that “CDS software functions,” as compared to non-CDS software functions, are those that are intended a) not to acquire, process, or analyze data; b) to display, analyze, or print data; and c) to support or provide clinical recommendations. The guidance then specifies the criteria for determining whether a CDS software function meets FDA’s long-standing definition of “medical device” and would thus undergo the normal regulatory process for approval prior to public use, or whether the function meets statutory exclusion criteria and would thus not be considered a medical device (but still considered a CDS software function.) For CDS software functions that are medical devices, the guidance also specifies when FDA for now will choose not to enforce regulatory compliance on those functions because they are intended to help with diagnosis or treatment of low-risk, non-serious conditions. The guidance does not explain how, if at all, FDA will regulate non-device CDS software functions.
CDS software that is not a medical device
The 21st Century Cures Act provided exclusion criteria that must all be met for a CDS software function to not be considered a medical device. Namely, these functions must meet the definition of a “CDS software function” but also must be intended for use solely by a healthcare provider and must allow that healthcare provider to make independent decisions without primarily relying on the software. The guidance provides examples of these qualifying non-device CDS software functions, such as software that matches a patient’s symptoms with well-accepted reference information from the medical community about how to treat for a disease that presents those symptoms, so long as the software allows for the healthcare provider to ultimately make the decision about what disease or condition the patient may actually have and what treatment options would be best for the patient.
CDS software that is a medical device but for which FDA will not enforce regulatory compliance
The guidance references a proposed risk-based framework from the International Medical Device Regulators Forum that categorizes CDS software functions based on the seriousness of the intended health condition the software would address and on how significant a role the software plays in making a healthcare decision. Using that framework, if a CDS software function is a medical device and is intended both to address non-serious medical conditions and to inform clinical management decisions, the FDA states through the guidance that they will choose not to enforce normal medical device regulations under two scenarios:
- The CDS software function is intended to be used by healthcare providers, not patients or caregivers, and the healthcare provider cannot independently review the basis of the recommendations provided by the software; or
- The CDS software function is intended to be used by patients or caregivers and those people can independently review the basis of the recommendations.
Examples the guidance provides of CDS software functions falling into this category include non-explainable machine learning algorithms used by healthcare providers to alert those healthcare providers about signs of non-serious medical issues, such as high cholesterol; or software that provides transparent recommendations to a patient about over-the-counter medicines that could be effective at treating the patient’s symptoms for a non-serious condition, such as colds or seasonal allergies.
CDS software that is a medical device and for which FDA will enforce regulatory compliance
In all other cases for CDS software functions that are medical devices, FDA will exercise its routine medical device regulations. This category applies for CDS software functions that are:
- Intended to inform clinical management decisions for serious or critical health conditions; or
- Intended to inform clinical management decisions of non-serious conditions and to be used by a patient or caregiver, in situations where those people cannot independently review the basis of the recommendations provided by the software.
Examples the guidance provides of CDS software functions falling into this category include non-explainable machine learning algorithms that predict likely flu symptoms per geographic region in each flu season, or software that recommends exactly when a caregiver should bring a child with cystic fibrosis into the hospital based on the symptoms they are presenting. Of note, the guidance specifies that software functions that aim to drive clinical management or to treat or diagnose conditions would not fall into the definition of CDS, and therefore this guidance does not apply to those software functions.