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Today’s Topic:

Final Guidance on Clinical Decision Support Software

October 18, 2022
2

Clinical Decision Support Software

Final Guidance

Center for Devices and Radiological Health

U.S. Food and Drug Administration

Sonja Fulmer, PhD

Acting Deputy Director

CDRH Digital Health Center of Excellence

Office of Strategic Partnerships and Technology Innovation

Jessica Paulsen

Division Director

Office of Cardiovascular Devices

Office of Product Evaluation and Quality

Director, Digital Health Focal Point Program
3

• Clinical Decision Support Software

– www.fda.gov/regulatory-information/search-fda-guidancedocuments/clinical-decision-support-software

–Docket Number: FDA-2017-D-6569

Final Guidance
4

Learning 

Objectives

 Describe purpose and scope of guidance

 Explain FDA’s current thinking on Clinical Decision 

Support (CDS), including which CDS software 

functions are considered devices

 Identify how the guidance:

 Clarifies criteria for non-device clinical decision 

support software functions

 Provides examples of clinical decision support 

software functions

 Complements other existing guidance documents 
5

Cures Act built on FDA’s digital health policies

Administrative 

support of a 

health care 

facility;

Maintaining or 

encouraging a 

healthy lifestyle 

with no 

reference to any 

disease or 

condition;

Electronic 

patient records;

Transferring, 

storing, 

converting 

formats, or 

displaying data 

and results;

Clinical decision 

support.

On December 13, 2016, the 21st Century Cures Act amended the definition of “device” in 

the Federal Food, Drug, and Cosmetic Act (FD&C Act) to exclude certain software functions

defined in section 520(o) of the FD&C Act. Specifically, 520(o) of the FD&C Act excludes 

software functions intended for:

520(o)(1)(A) 520(o)(1)(B) 520(o)(1)(C) 520(o)(1)(D) 520(o)(1)(E)

Guidance: Changes to Existing Medical Software Policies Resulting 

from Section 3060 of the 21st Century Cures Act
6

Background

Dec 2016: 21st Century Cures Act:

Amended device definition

Dec 2017: First Draft Guidance:

“Clinical and Patient Decision Support Software”

Sept 2019: Revised Draft Guidance:

“Clinical Decision Support Software”

Sept 2022: Final Guidance:

“Clinical Decision Support Software”
7

CDS includes:2

• computerized alerts and reminders for providers and patients;

• clinical guidelines;

• condition-specific order sets;

• focused patient data reports and summaries;

• documentation templates;

• diagnostic support;

• contextually relevant reference information.

What is Clinical Decision Support (CDS)?

1See Office of the National Coordinator for Health Information Technology, “What is Clinical Decision Support (CDS)?” at www.healthit.gov/topic/safety/clinicaldecision-support

2FDASIA Health IT Report, April 2014, available at www.fda.gov/about-fda/cdrh-reports/fdasia-health-it-report

Clinical Decision Support (CDS) is a tool that provides health care professionals and patients with 

knowledge and person-specific information, intelligently filtered or presented at appropriate times, to 

enhance health and health care.1
8

2019 Revised Draft Guidance

Guidance Summary

FDA issued Draft Guidance in September 2019 to 

provide FDA’s interpretation of the types of 

Clinical Decision Support (CDS) software 

excluded from the device definition by the 21st

Century Cures Act. This draft guidance described: 

(1) CDS software that is no longer under FDA’s 

jurisdiction based on the Cures Act, 

(2) CDS software for which FDA does not intend 

to enforce compliance with regulatory 

requirements, and 

(3) CDS software for which FDA continues to 

focus its regulatory oversight.

67 Comments Received on Revised Draft

Summary of Comments

• Suggested changes to Enforcement Discretion Policy 

• Requested explanation of difference between the terms “signal” and “medical 

information” for determining whether the software function is Device CDS or Nondevice CDS

• Highlighted need to understand the application of the IMDRF Risk Categorization 

Framework, particularly in the difference between the categories of “Inform Clinical 

Management” and “Drive Clinical Management” 

• Sought elaboration on how Artificial Intelligence/Machine Learning functions can be 

explained and understood

IMDRF = International Medical Device Regulators Forum
9

• Additional clarity on each of the criteria from section 520(o)(1)(E) of the FD&C Act 

– Better explains distinction between “signal, pattern, medical image” (Criterion 1) and “medical 

information” (Criterion 2) for purposes of determining if Non-Device criteria are met

– Provides information and examples to illustrate how healthcare professionals can independently 

review the basis of the software recommendations (including for AI/ML)

• IMDRF Risk Categorization Framework is not used in interpretation of Non-Device CDS 

criteria

• Does not include enforcement discretion policies proposed in draft guidance

• Additional explanation and examples to clarify these policies, including identifying 

complementary existing digital health guidances

Summary of Changes from 2019 Revised Draft
10

• Guidance describes CDS that does not meet the definition of a device (Non-Device CDS) 

including certain CDS software functions intended for HCPs. 

• Guidance does not address:

– which FDA statutory or regulatory requirements apply to device software functions;

– which regulatory requirements may apply to a device software function that is part of a 

combination product;

– labeling requirements for decision support software disseminated by or on behalf of a 

drug or biological product sponsor.

Final Guidance Scope

This guidance presents the agency’s current thinking on which CDS software functions are excluded 

from the definition of device by the criteria in section 520(o)(1)(E) of the FD&C Act. 
11

• The functions excluded from the device definition are independent of the 

platform on which they might run.

• The term Non-Device CDS is used to refer to decision support software 

functions that do not meet the definition of device in section 201(h) of the 

FD&C Act.

Interpretation of Criteria in Section 520(o)(1)(E) 

of the FD&C Act 

A software function must meet all of the four statutory criteria in section 520(o)(1)(E) of the FD&C Act 

to be excluded from the device definition.
12

21st Century Cures Criteria for Non-Device 

Clinical Decision Support (CDS)

1) NOT intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device or 

a pattern or signal from a signal acquisition system;

2) intended for the purpose of displaying, analyzing, or printing medical information about a patient or other 

medical information (such as peer-reviewed clinical studies and clinical practice guidelines);

3) intended for the purpose of supporting or providing recommendations to a health care professional about 

prevention, diagnosis, or treatment of a disease or condition; and 

4) intended for the purpose of enabling a health care professional to independently review the basis for such 

recommendations that such software presents so that it is not the intent that such health care professional 

rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an 

individual patient.

The Cures Act excludes certain software functions from device definition if all four

of these Criteria are met:
13

Criterion (1): Acquire, Process, Analyze

520(o)(1)(E)

Not intended to acquire, 

process, or analyze a 

medical image or a signal 

from an in vitro diagnostic 

device or a pattern or 

signal from a signal 

acquisition system

CDS Guidance

If the type of data described in Criterion 1 (i.e., medical 

image or a signal from an IVD or a pattern/signal from a 

signal acquisition system) is acquired, processed, or 

analyzed (used as an input), then the software function 

remains a device within the meaning of section 201(h). 

Such products have been regulated as devices for many 

years.
14

Criterion (1): Medical Image

CDS Guidance

We generally consider the term medical image to include 

images generated by use of medical imaging systems (e.g., 

computed tomography (CT), x-ray, ultrasound, magnetic 

resonance imaging (MRI)) to view any part(s) of the body 

or images acquired for a medical purpose (e.g., pathology, 

dermatology). 

Images that were not originally acquired for a medical 

purpose but are being processed or analyzed for a medical 

purpose are also considered medical images. 
15

Criterion (1): Signal

CDS Guidance

We generally consider the term signal to include those signals that typically require use 

of either: 

• An IVD, which can include an electrochemical or photometric response generated 

by an assay and instrument that may be further processed by software to generate 

a clinical test result; or

• A signal acquisition system that measures a parameter from within, attached to, or 

external to the body for a medical purpose and often includes but is not limited to: 

– use of sensors (e.g., electrocardiogram (ECG) leads) along with electronics and 

software function that is used for signal generation (e.g., ECG); 

– collections of samples or specimens such as tissue, blood, or other fluids (e.g., 

conducting a pathological study using software such as digital pathology); or

– use of radiological imaging systems (e.g., computed tomography (CT)) and a 

software function for image generation.

“Electrochemical responses of the electrochemical biosensor at different concentrations of E. coli O157:H7 and Vibrio cholerae O1” by : 

Xiong, Ya & Fang, Lichao & Jiang, Lili & Huang, Hui & Deng, Jun & Liang, Wenbin & Zheng, Junsong is licensed under CC BY-NC 4.0
16

Criterion (1): Pattern

CDS Guidance

FDA interprets the term pattern in this provision to refer to multiple, 

sequential, or repeated, measurements of a signal or from a signal 

acquisition system. Examples of patterns include: 

• For ECG, an electrical signal acquired from the body is processed to create an ECG 

waveform and QRS complex;

• For Next Generation Sequencing (NGS), a fluorescent signal on tagged DNA is 

processed by modification or transformation into base pairs and sequences. Genetic 

sequences, including datasets of sequence variants that differ from reference 

sequences and datasets filtered to represent disease-associated variations (such as 

variant call format files or VCFs); and

• For continuous glucose monitors (CGM), a photometric or electrochemical signal 

generated by an assay and instrument is processed to generate repeated glucose 

measurements over time. 
17

Criterion (1): Clinical relevance

CDS Guidance

FDA considers software functions that assess or interpret the 

clinical implications or relevance of a signal, pattern, or medical 

image to be software functions that do not meet Criterion 1 

because they acquire, process, or analyze. Examples:

- Image: Enhancing, manipulating, measuring, identifying structures

- ECG: Measuring repeated complexes, detecting arrhythmias

- NGS: Identifying genetic variants or clinical implications

- IVD: Generating a clinical test result

10mm = 1 mV 

P

Q

S

R

T

P

PR ST

QT

0.20 sec

QRS
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Criterion (2): Medical Information

520(o)(1)(E)(i)

Intended for the purpose 

of displaying, analyzing, or 

printing medical 

information about a 

patient or other medical 

information (such as peerreviewed clinical studies 

and clinical practice 

guidelines)

CDS Guidance

• Non-device CDS are intended to display, analyze, or print 

medical information about a patient or other medical 

information. 

• What is medical information? 

– demographic information, symptoms, 

– test results, certain medical device outputs (such as a heart rate or 

blood pressure reading), 

– patient discharge summaries, 

– other medical information, such as clinical practice guidelines, peerreviewed clinical studies, textbooks, approved drug or medical device 

labeling, and government agency recommendations
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Criterion (2): What is Medical Information?

CDS Guidance

• The kind of information used by the intended user to make 

decisions about prevention, diagnosis, or treatment of a disease 

or condition for an individual patient. 

– Normally is, and generally can be, communicated between HCPs or 

HCPs/patients

• FDA interprets medical information about a patient to be 

information whose relevance to a clinical decision is well 

understood and accepted in the practice of medicine. 
20

Criterion (2): What is Medical Information?

CDS Guidance

Sampling frequency is also an important consideration:

• A single, discrete test or measurement result that is clinically 

meaningful (e.g., a blood glucose lab test result) = medical information

• More continuous sampling of the same information (e.g., continuous 

glucose monitor readings) = a pattern/signal

Examples of medical information:

• The report from a radiology study or summary information about the 

output of legally marketed CAD software

• An ECG report annotated by an HCP with a description of an abnormal 

heart rhythm 

• A blood pressure result from a legally marketed device

• A lab test result in an electronic health record

Electronic Health 

Record

“The patient 

shows sign of Atrial 

Fibrillation”

0.5

0.0

R R

-0.5

1.0

1.5

Amplitude (mv)

Time (sec)

1.0 1.5 2.0 2.5 3.0
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Criterion (3): Intended User is HCP

520(o)(1)(E)(ii)

Intended for the purpose of 

supporting or providing 

recommendations to an 

HCP about prevention, 

diagnosis, or treatment of a 

disease or condition

CDS Guidance

• Non-Device CDS software functions are intended to support or 

provide recommendations to an HCP about prevention, 

diagnosis, or treatment of a disease or condition. 

– Software functions that support or provide such recommendations 

to patients or caregivers – not HCPs – therefore remain in the 

definition of device. 

– FDA intends to be consistent with existing software policies in the 

regulation of CDS intended for non-HCPs.

• Assist HCPs in making patient-specific care decisions. 
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Criterion (3): Supporting/Providing Recommendations

Criterion 3

FDA interprets Criterion 3 to refer to software that:

 provides condition-, disease-, and/or patient-specific 

information and options to an HCP to enhance, inform and/or 

influence a health care decision;

 does not provide a specific preventive, diagnostic or 

treatment output or directive;

 is not intended to support time-critical decision-making; and

 is not intended to replace the HCP’s judgment.

CDS Guidance
23

Outputs that meet Criterion (3)

• List of preventive, diagnostic or treatment 

options;

• Prioritized list of preventive, diagnostic or 

treatment options; or

• List of follow-up or next-step options for 

consideration (e.g., after a physician office 

visit, hospitalization, procedure)

Outputs that do not meet Criterion (3)

• Provides a specific preventative, diagnostic or 

treatment course; 

• Provides a specific follow-up directive; 

• Provides time-critical alarms or alerts intended 

to trigger potential clinical intervention to 

assure patient safety; or

• Provides a treatment plan for a specific 

patient’s disease or condition.

Criterion (3): Supporting/Providing Recommendations
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Criterion (3): Supporting/Providing Recommendations

CDS Guidance

Examples of Non-Device CDS software functions include software functions 

that provide:

• Evidence-based clinician order sets for an HCP to choose from, tailored for 

a particular condition, disease, or clinician preference;

• Matching patient-specific medical information from records or reports to 

reference information (e.g., clinical guidelines);

• Contextually relevant reference information about a disease or condition;

• Drug-drug interaction and drug-allergy contraindication notifications to 

avert adverse drug events; 

• Drug formulary guidelines;

• Duplicate testing or prescription product prevention notifications (e.g., 

medication reconciliations and test reconciliations); 

• Reminders for preventive care or clinician orders; and

• Patient data reports and summaries (e.g., discharge papers). 
25

Criterion (4): Independent Review

520(o)(1)(E)(iii)

Intended for the purpose of 

enabling an HCP to independently 

review the basis for the 

recommendations that such 

software presents so that it is not 

the intent that the HCP rely 

primarily on any of such 

recommendations to make a 

clinical diagnosis or treatment 

decision regarding an individual 

patient

CDS Guidance

Non-Device CDS are intended to enable HCPs to 

independently review the basis for the recommendations 

presented by the software so that they do not rely 

primarily on such recommendations, but rather on their 

own judgment, to make clinical decisions for individual 

patients. 
26

Criterion (4): Enabling Independent Review

HCP Independent Review CDS Guidance

In order to satisfy Criterion 4, FDA recommends that:

a) The software or labeling include the purpose or intended use of the product, 

including the intended HCP user [can’t be time-critical]

b) The software or labeling identify the required input medical information

c) The software or labeling provide a plain language description of the underlying 

algorithm development and validation that forms the basis for the CDS 

implementation

i. Summary of the logic or methods (e.g., AI/ML techniques)

ii. Description of the data relied upon

iii. Description of results from clinical validation studies

d) The software output provide relevant patient-specific information and other 

knowns/unknowns for consideration
27

Examples: Non-Device CDS

These examples are intended to illustrate FDA’s interpretation of the first three criteria in section 520(o)(1)(E) of the FD&C Act: 

software functions considered Non-Device CDS provided that they also meet Criterion 4.

Some examples of non-device CDS include a software function that ...

... identifies drug-disease 

interactions and contraindications, 

such as notifying an HCP that a 

patient with asthma should not be 

prescribed a non-selective betablocking drug.

... aggregates possible postoperative care instructions, 

medication needs, and follow-up 

instructions to assist an HCP in 

assembling discharge papers for a 

patient.

... provides alerts to HCPs regarding 

changes in a formulary and 

recommends alternatives.

... analyzes medical information on 

a patient’s asthma diagnosis and 

demographics from the patient’s 

medical record and provides an HCP 

with a list of FDA-approved 

treatment options for asthma. 

... analyzes blood glucose laboratory test results and prediabetes diagnosis from a patient’s medical record and 

provides an HCP with a list of next-step options to 

consider, such as more frequent office visits or referral to a 

specialist. 
28

Example: Non-Device CDS that meets Criterion 4

Software function that recommends a prioritized list of FDA-approved chemotherapeutic agents (approved for the patient’s 

diagnosed cancer type) to an HCP based on analysis of reported outcomes in a database of clinical studies using the patient’s

diagnosis and demographics from the medical record. To enable HCPs to independently review the basis for the recommendations 

presented by the software so that they do not rely primarily on such recommendations, but rather on their own judgment, the 

following information is provided to the HCP: 

The intended use, HCP user, and patient population are clearly 

identified. The use is not time-critical and the intended HCP is 

expected to have sufficient time and training to assess the clinical 

studies that are the basis of the recommendations;

Information about how the clinical studies included were 

selected, the full reports of the clinical studies being relied 

upon are clearly identified, with a brief summary of the 

strength of each study (e.g., number of patients, outcome 

metrics, randomization, comparison arm), and the key 

elements of the diagnosis or demographics searched for in 

the medical record are noted; and

The cancer diagnosis and patient demographics are clearly 

identified as the inputs being used in the database search 

and analysis;

The prioritized list of FDA-approved chemotherapeutic agents 

and the basis of the prioritization is provided to the HCP, and the 

studies that most closely matched the patient-specific diagnosis 

and demographics are identified. Other considerations, such as 

the warnings and contraindications from the current version of 

the FDA-approved drug labeling, are also provided to the HCP for 

consideration prior to making a final decision.
29

Example: Non-Device CDS that meets Criterion 4

Software function that recommends a prioritized list of FDA-approved chemotherapeutic agents (approved for the patient’s 

diagnosed cancer type) to an HCP based on analysis of reported outcomes in a database of clinical studies using the patient’s

diagnosis and demographics from the medical record. To enable HCPs to independently review the basis for the recommendations 

presented by the software so that they do not rely primarily on such recommendations, but rather on their own judgment, the 

following information is provided to the HCP: 

The intended use, HCP user, and patient population are clearly 

identified. The use is not time-critical and the intended HCP is 

expected to have sufficient time and training to assess the clinical 

studies that are the basis of the recommendations;

Information about how the clinical studies included were 

selected, the full reports of the clinical studies being relied 

upon are clearly identified, with a brief summary of the 

strength of each study (e.g., number of patients, outcome 

metrics, randomization, comparison arm), and the key 

elements of the diagnosis or demographics searched for in 

the medical record are noted; and

The cancer diagnosis and patient demographics are clearly 

identified as the inputs being used in the database search 

and analysis;

The prioritized list of FDA-approved chemotherapeutic agents 

and the basis of the prioritization is provided to the HCP, and the 

studies that most closely matched the patient-specific diagnosis 

and demographics are identified. Other considerations, such as 

the warnings and contraindications from the current version of 

the FDA-approved drug labeling, are also provided to the HCP for 

consideration prior to making a final decision.
30

Example: Non-Device CDS that meets Criterion 4

Software function that recommends a prioritized list of FDA-approved chemotherapeutic agents (approved for the patient’s 

diagnosed cancer type) to an HCP based on analysis of reported outcomes in a database of clinical studies using the patient’s

diagnosis and demographics from the medical record. To enable HCPs to independently review the basis for the recommendations 

presented by the software so that they do not rely primarily on such recommendations, but rather on their own judgment, the 

following information is provided to the HCP: 

The intended use, HCP user, and patient population are clearly 

identified. The use is not time-critical and the intended HCP is 

expected to have sufficient time and training to assess the clinical 

studies that are the basis of the recommendations;

Information about how the clinical studies included were 

selected, the full reports of the clinical studies being relied 

upon are clearly identified, with a brief summary of the 

strength of each study (e.g., number of patients, outcome 

metrics, randomization, comparison arm), and the key 

elements of the diagnosis or demographics searched for in 

the medical record are noted; and

The cancer diagnosis and patient demographics are clearly 

identified as the inputs being used in the database search 

and analysis;

The prioritized list of FDA-approved chemotherapeutic agents 

and the basis of the prioritization is provided to the HCP, and the 

studies that most closely matched the patient-specific diagnosis 

and demographics are identified. Other considerations, such as 

the warnings and contraindications from the current version of 

the FDA-approved drug labeling, are also provided to the HCP for 

consideration prior to making a final decision.
31

Example: Non-Device CDS that meets Criterion 4

Software function that recommends a prioritized list of FDA-approved chemotherapeutic agents (approved for the patient’s 

diagnosed cancer type) to an HCP based on analysis of reported outcomes in a database of clinical studies using the patient’s

diagnosis and demographics from the medical record. To enable HCPs to independently review the basis for the recommendations 

presented by the software so that they do not rely primarily on such recommendations, but rather on their own judgment, the 

following information is provided to the HCP: 

The intended use, HCP user, and patient population are clearly 

identified. The use is not time-critical and the intended HCP is 

expected to have sufficient time and training to assess the clinical 

studies that are the basis of the recommendations;

Information about how the clinical studies included were 

selected, the full reports of the clinical studies being relied 

upon are clearly identified, with a brief summary of the 

strength of each study (e.g., number of patients, outcome 

metrics, randomization, comparison arm), and the key 

elements of the diagnosis or demographics searched for in 

the medical record are noted; and

The cancer diagnosis and patient demographics are clearly 

identified as the inputs being used in the database search 

and analysis;

The prioritized list of FDA-approved chemotherapeutic agents 

and the basis of the prioritization is provided to the HCP, and the 

studies that most closely matched the patient-specific diagnosis 

and demographics are identified. Other considerations, such as 

the warnings and contraindications from the current version of 

the FDA-approved drug labeling, are also provided to the HCP for 

consideration prior to making a final decision.
32

Example: Non-Device CDS that meets Criterion 4

Software function that recommends a prioritized list of FDA-approved chemotherapeutic agents (approved for the patient’s 

diagnosed cancer type) to an HCP based on analysis of reported outcomes in a database of clinical studies using the patient’s

diagnosis and demographics from the medical record. To enable HCPs to independently review the basis for the recommendations 

presented by the software so that they do not rely primarily on such recommendations, but rather on their own judgment, the 

following information is provided to the HCP: 

The intended use, HCP user, and patient population are clearly 

identified. The use is not time-critical and the intended HCP is 

expected to have sufficient time and training to assess the clinical 

studies that are the basis of the recommendations;

Information about how the clinical studies included were 

selected, the full reports of the clinical studies being relied 

upon are clearly identified, with a brief summary of the 

strength of each study (e.g., number of patients, outcome 

metrics, randomization, comparison arm), and the key 

elements of the diagnosis or demographics searched for in 

the medical record are noted; and

The cancer diagnosis and patient demographics are clearly 

identified as the inputs being used in the database search 

and analysis;

The prioritized list of FDA-approved chemotherapeutic agents 

and the basis of the prioritization is provided to the HCP, and the 

studies that most closely matched the patient-specific diagnosis 

and demographics are identified. Other considerations, such as 

the warnings and contraindications from the current version of 

the FDA-approved drug labeling, are also provided to the HCP for 

consideration prior to making a final decision.
33

Example: Device Software Function

Function Description Rationale

Software function that analyzes sound waves when 

users cough or recite certain sentences to diagnose 

bronchitis or sinus infection. (Example #15 in 

guidance) 

This software is a device function because:

X Criterion 1 It analyzes a signal or pattern.

X Criterion 2 It is not intended to display, analyze, or 

print Medical Information.

X Criterion 3 It provides a specific diagnostic output or 

directive.

Software function that uses a variant call format 

(VCF) file containing patient-specific genetic variants 

and mutations identified from a Next Generation 

Sequencing (NGS) Analyzer and provides 

recommendations for FDA-approved treatment 

options based on those findings. (Example #18 in 

guidance) 

This software is a device function because:

X Criterion 1 It analyzes a pattern.

X Criterion 2 It is not intended to display, analyze, or 

print Medical Information.

✔Criterion 3 

These examples focus on the first three criteria in section 520(o)(1)(E). Other examples focus on the interpretation of criterion 4.
34

Function Description Rationale

Software function that analyzes an ECG waveform 

output from an FDA cleared device to detect or 

diagnose arrhythmias (e.g., atrial fibrillation). 

(Example #20 in guidance)

This software is a device function because:

X Criterion 1 It analyzes a pattern.

X Criterion 2 It is not intended to display, analyze, or 

print Medical Information.

X Criterion 3 It provides a specific diagnostic output.

Software function that analyzes five sequential RR 

interval measurements from Holter monitor data in 

a patient medical record to identify a possible heart 

rhythm irregularity and recommend follow-up 

testing. (Example #22 in guidance) 

This software is a device function because:

X Criterion 1 It analyzes a pattern (due to sampling 

frequency of RR interval measurements).

X Criterion 2 It is not intended to display, analyze, or 

print Medical Information.

X Criterion 3 It provides a specific diagnostic output or 

directive.

Example: Device Software Function

These examples focus on the first three criteria in section 520(o)(1)(E). Other examples focus on the interpretation of criterion 4.
35

Function Description Rationale

Software function intended for HCP management of 

heart failure patients that analyzes patient-specific 

medical information (e.g., daily heart rate, SpO2, 

blood pressure, or other output from wearable 

product) to predict heart failure hospitalization.

(Example #24 in guidance) 

This software is a device function because:

✔Criterion 1 

✔Criterion 2

X Criterion 3 It provides a specific diagnostic output or 

directive and supports time-critical decision making.

Software function that analyzes a radiologist’s 

score/report of regional contrast discrepancies 

measured from a head CT of a suspected stroke 

patient to identify whether the HCP should initiate a 

specific drug therapy based on a scoring algorithm.

(Example #27 in guidance) 

This software is a device function because:

✔Criterion 1 

✔Criterion 2

X Criterion 3 It provides a specific treatment output or 

directive and supports time-critical decision making.

Example: Device Software Function

These examples focus on the first three criteria in section 520(o)(1)(E). Other examples focus on the interpretation of criterion 4.
36

Function Description Rationale

Software function that identifies a specific FDAapproved chemotherapeutic agent to an HCP based 

on analysis of patient diagnosis and pathologist 

confirmed biopsy results. (Example #29 in guidance) 

This software is a device function because:

✔Criterion 1 

✔Criterion 2

X Criterion 3 It provides a specific treatment output or 

directive.

Software function that helps a diabetic patient 

manage their blood sugar by calculating bolus 

insulin dose based on carbohydrate intake, pre-meal 

blood glucose, and anticipated physical activity 

reported to adjust carbohydrate ratio and basal 

insulin. (Example #30 in guidance) 

This software is a device function because:

✔Criterion 1 

✔Criterion 2

X Criterion 3 It is not intended for an HCP and it 

provides a specific treatment output or directive and 

supports time-critical decision-making.

Example: Device Software Function

These examples focus on the first three criteria in section 520(o)(1)(E). Other examples focus on the interpretation of criterion 4.
37
38

We have made corresponding changes through Level 2 

Updates to other Digital Health Guidances
39

We have issued an interactive tool to introduce digital 

health policies to stakeholders

This tool incrementally 

introduces policy 

considerations with plain 

language to establish 

baseline understanding of 

policies and pathways

Interactive accessible 

format with simplified 

questions and YES or NO 

answers; and layered 

supporting information.

www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-policy-navigator
40

• CDS Final Guidance focuses on the statutory criteria describing Non-Device clinical 

decision support software functions

– Clarifies scope of FDA oversight of clinical decision support software intended for 

health care professionals as devices

• Guidance provides examples of how FDA intends to consider different kinds of software 

functions, including non-device clinical decision support functions and device functions

• If unsure of how to apply the guidance/Non-Device CDS criteria:

– Reach out to DigitalHealth@fda.hhs.gov

– Consider submitting 513(g) for device determination or Q-Sub for discussion

Summary

42

Additional Panelist

Brendan O’Leary

Acting Director

CDRH Digital Health Center of Excellence

Office of Strategic Partnerships and Technology Innovation 

Center for Devices and Radiological Health

U.S. Food and Drug Administration
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