Does software that analyzes EHR blood test results meet FDA CDS criterion 1?

Question

Our company has a device that analyzes blood test results, biological sex, and age, with all input information coming from the electronic health record (EHR). According to the new FDA guidance on clinical decision support (CDS) systems, does this scenario meet criterion 1 for exclusion from the device definition?

Dr. Oliver Eidel · Accepted Answer

Yes, based on the FDA's guidance, you likely meet criterion 1. The guidance clarifies that analyzing results (e.g., blood test outcomes) rather than direct measurements or patterns from a signal acquisition system fits criterion 1. For example, they mention that software providing a list of cholesterol-lowering drugs based on EHR cholesterol levels and demographics is a Non-Device MDDS and meets criterion 1. If your device uses analyzed results from the EHR, it aligns with this example and does not analyze raw measurements or patterns.

Answer

I attended a recent FDA webinar where they clarified that single measurements from an EHR are considered "medical information" and not "signals," so you probably meet both criteria 1 and 2. However, make sure to review criteria 3 and 4 as well—you need to meet all four exclusionary criteria to be considered a non-device CDS. If your analysis provides specific diagnostic or treatment recommendations, or if the healthcare professional can't independently review the basis for the output, then you may still be considered a device. Check out the examples in the FDA guidance for more detail.

Does software that analyzes EHR blood test results meet FDA CDS criterion 1?

2 Answers

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