Clinical Decision Support Software

by | Oct 28, 2019 | Clinical Trials, FDA, Medical Devices, Quality Systems, Regulatory, Requirements, Software

Clinical Decision Support Software is a tool that is utilized in making decisions for the diagnosis, treatment, prevention, cure or mitigation of diseases and other critical conditions. Such a tool provides clinicians, health care staff or patients with intelligently filtered patient specific data extracted from their medical records at appropriate times to guide clinical decisions.1 The information obtained by clinicians and other practitioners can be categorized as follows : Clinical guidelines, reminders for providers and patients, computerized alerts, condition-specific order sets, documentation templates, diagnostic support, focused patient data reports and summaries. By adopting and implementing such a tool, there can be drastic improvements in the quality of care provided to the patients with the help of information obtained from the software. CDS software can potentially assist in the prevention of errors in decision making by evaluating health data and providing medication error alerts, including any allergy indications, thus avoiding adverse health effects.2

FDA’s regulatory approach to CDS software has been outlined in the draft guidance document “Clinical Decision Support Software” released on September 27, 2019.3 Moreover, changes that were made in the 21st Century Cures Act have also been incorporated into this draft guidance. The guidance clarifies the types of software functions that: (1) do not meet the definition of a device as amended by the Cures Act; (2) may meet the definition of a device but for which, at this time and based on FDA’s current understanding of the risks of these devices, premarket clearance or premarket approval requirements may not be applicable; & (3) meet the definition of a device and on which FDA intends to focus its regulatory oversight. Furthermore, FDA intends to enforce Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations (IMDRF framework) for the oversight of CDS software.4

At this point, FDA does not intend to regulate CDS software that fall into the low risk category of the IMDRF classification system. This includes non-device CDS function in cases where health care professionals do not depend on the software recommendations even if the healthcare situation or condition is serious, non-serious or critical. However, FDA intends to impose its regulatory oversight for the Device CDS software functions that are utilized for:

  • Treatment of serious or critical situation.
  • Providing Clinical management with information regarding a serious or critical situation.
  • Situations when patients or health care professionals cannot independently assess the basis for software recommendations.5

The guidance document is still in its draft stage and is open for public comments. If you would like to submit your comments, visit

Need help understanding this, or any other FDA guidance, give us a call at 248-987-4497 or email (April 2018) “Clinical Decision Support” retrieved from on 10/22/2019

2Sima Ajemi and Fatemeh Amini (December 2012) “ Reduce Medication Errors with Clinical Decision Support System ” retrieved from “ ” on 10/23/2019

3FDA (September 2019) “ Clinical Decision Support Software, Guidance for Industry and Food and Drug Administration Staff ” retrieved from “”   on 10/22/2019

4IMDRF Software as Medical Device Working Group (September 2014) “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations” retrieved from “” on 10/22/2019

5FDA (September 2019) “ Clinical Decision Support Software ” retrieved from   “ ” on 10/23/2019


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More Resources

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

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