New version of FDA guidance on Clinical Decision Support Software
By Mitch on Friday, 23 January 2026, 14:07 - Regulations - Permalink
A new version of the FDA Guidance on Clinical Decision Support Software (CDSS) was published in January 2026. Here is a review of the new cases presented in the document and a short comparison with the status of CDSS with regard to the MDR.
This post is an update of the previous blog post of 2023, analysing of the previous version of the guidance.
Criterion 3
The FDA added new cases to the guidance. Here is a comparison of these cases with their MDR status. The "however" cases present in the FDA guidance are not taken here, they are obviously in the scope of MDR medical device definition.
Note 1: most of FDA examples below require the output be "reviewed, revised, and finalized by the HCP", or some similar language. There no equivalent consideration of review of the output neither in the MDR definitions, nor in MDCG guides, nor in the manual on borderline qualification.
Note 2: the guidance now adds the case where if software gives only one recommendation, then it is subject to "law enforcement discretion". When only one specific recommendation is given, the software is definitely an aid to diagnosis or treatment and thus matches the MDR medical device definition ; unless it points to an existing guideline (see one case below).
| Software Function | MDR qualification |
|---|---|
| A software function that predicts risk of future cardiovascular events for an HCP to consider based on a patient’s weight, current and historical smoking status, blood pressure, and brain natriuretic peptide (BNP) in vitro diagnostic (IVD) test results. | This is an aid to diagnosis. This is a medical device software in class IIa or higher. It could be qualified as IVD device if the IVD test result is the main information used to output diagnosis. |
| A software function that creates a recommended treatment plan, including possible medication(s), for patients diagnosed with cognitive impairment for an HCP to consider based on the patient’s diagnosis related to cognitive impairment as well as potential comorbidities, age, sex, and patient preferences, and that should be reviewed, revised, and finalized by an HCP | This is an aid to treatment. This is a medical device software in class IIa or higher. Note that the software "creates a treatment plan". It doesn't displays an existing treatment recommendation from an existing guideline. |
| A software function that recommends a specific FDA-approved antibiotic agent for an HCP to consider based on the patient’s symptoms, recent hospitalizations, and previous antibiotic exposure. | This is an aid to treatment in class IIa or higher. In the EU, a software recommending an EMA-approved antibiotic agent is a medical device software. |
| A software function that analyzes a radiologist’s clinical findings of an image to generate a proposed summary of the clinical findings for a patient’s radiology or pathology report, including a specific diagnostic recommendation based on clinical guidelines that should be reviewed, revised, and finalized by an HCP | The proposed summary can be seen as clinical data communication and is not qualified as medical device. The recommendation based on clinical guidelines can be probably seen as "simple search", not MD. The Manual on Borderline and Classification V1.22 of 2019 contains a somewhat similar case at section 9.4. Qualification of software for interpretation of a guideline. |
| A software function that provides an HCP with a differential diagnosis based on a patient’s symptoms, vital signs, and laboratory values, and that, depending on the clinical context, may present either multiple diagnostic considerations or a single clinically appropriate diagnostic recommendation when alternative diagnoses are highly improbable. The output is intended to support clinical reasoning and to be reviewed, revised, and finalized by the HCP. | This is an aid to diagnosis. This is a medical device software in class IIa or higher. |
| A software function that classifies patients with chronic low back pain into a single recommended appropriate clinical care pathway (e.g., conservative management or referral to a surgical spine specialist) based on patient history, symptom duration, and documented clinical findings, where the recommendation is intended to be reviewed and acted upon by an HCP | This is an aid to treatment, in class IIa or higher. This is a medical device software. |
| A software function that estimates 90-day and 1-year postoperative mortality and complication risk following lung transplantation based on patient-specific clinical characteristics and published clinical evidence, where the output is intended to support pre-transplant planning and shared decision-making and is reviewed by an HCP. | This is an aid to prognosis. This is a medical device software. It may be in class I (no diagnosis or treatment) with a carefully crafted intended use . |
Criterion 4
The FDA slightly changed the language about labelling of devices matching the fourth criterion. This change isn't relevant to exclude any software from the MDR definition scope. Likewise, the FDA added considerations about usability, automation bias, or timeliness of output data. Such considerations won't save any software from the MDR definition scope either.
Conclusion
The cases added to the 2026 version of the guidance are all medical devices according to the MDR medical device definition, excepted one. We retrieve the same situation as the 2022 version, where FDA cases are outside medical device scope in the US and inside medical scope in the EU.
