1 

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Applying Human Factors 

and Usability Engineering 

to Medical Devices: 

Guidance for Industry and 

FDA Staff

Shannon Hoste, MSSE,MSM,RAC

Xin Feng, Ph.D.

Hanniebey Wiyor, Ph.D.
3 

Overview 

• Relevant regulations and standards

• FDA’s Human Factors guidance

• List of highest priority devices for 

human factors review – draft 

guidance
4 

Regulatory Basis for HF at FDA

21 CFR 820.30...

(c) Design Input... design requirements “address the intended 

use of the device, including the needs of the user and 

patient”...

(f) Design Verification...“confirm that the design output 

meets the design input requirements”... 

(g) Design Validation...”ensure that devices conform to 

defined user needs and intended uses and shall include 

testing of production units under actual or simulated use 

conditions. Design validation shall include software validation 

and risk analysis, where appropriate.”
5 

Regulatory Basis for HF at FDA

Medical Devices; Current Good Manufacturing Practice (cGMP); 

Quality System Regulation Preamble to Final Rule 21 CFR Parts 

808, 812, and 820 (61 FR 52502) 

i.72. ...”when designing a device, the manufacturer should 

conduct appropriate human factors studies, analyses, and tests 

from the early stages of the design process until that point in 

development at which the interfaces with the medical 

professional and the patient are fixed..”

i.159. ... “FDA emphasizes that any death, even if the 

manufacturer attributes it to user error, will be considered 

relevant by FDA and will have a high risk potentially associated 

with it. User error is still considered to be a nonconformity

because human factors and other similar tools should have been 

considered during the design phase of the device.”
6 

Human Factors Standards

AAMI/ANSI HE75:2009

• General considerations and 

principles 

– Managing the risk of use error

– Usability testing

• Design elements

– Controls

– Software

• Integrated solutions

– Mobile medical devices

– Home health care
7 

Human Factors Standards

ANSI/AAMI/IEC 62366 1:2015

Medical devices – Part 1: 

Application of usability 

engineering to medical devices

• Usability engineering process

• Accompanying document

• Training
8 

Human Factors Standards

ANSI/AAMI/ISO 

14971:2007 [R2010]

Medical devices – 

Application of risk 

management to medical 

devices

• Risk management

• Risk analysis

• Risk evaluation

• Evaluation of overall 

residual risk acceptability
9 

2015 FDA HF Guidance

Applying Human Factors 

and Usability 

Engineering to Medical 

Devices

As of April 3, 2016, this 

document supersedes 

“Medical Device Use-Safety: 

Incorporating Human Factors 

Engineering into Risk 

Management” issued July 18, 

2000. 
10

Overview of changes from the 2011 

Draft HF Guidance

Scope aims to clarify expectations around when to 

submit a HF report with a premarket submission

“CDRH recommends that manufacturers consider human 

factors testing for medical devices as a part of a robust 

design control subsystem. CDRH believes that for those 

devices where an analysis of risk indicates that users 

performing tasks incorrectly or failing to perform tasks 

could result in serious harm, manufacturers should 

submit human factors data in premarket submissions 

(i.e., PMA, 510(k)).” 
11

Overview of changes from the 2011 

Draft HF Guidance

Key terms (from Section 3 Definitions):

• Critical task - A user task which, if performed incorrectly 

or not performed at all, would or could cause serious 

harm to the patient or user, where harm is defined to 

include compromised medical care.

• User interface - All points of interaction between the user 

and the device... (including packaging, labeling, and 

training) and all physical controls and display elements...
Human Factors Validation Testing 

(Section 8)

Define intended users, use 

environments and user 

interface

Identify use-related hazards

Identify and categorize critical 

tasks

Develop and implement risk 

mitigation/control measures

Validate use safety and 

effectiveness

Use-related 

risks 

acceptable?

New userelated risks 

introduced?

Document HFE/UE process

YES

NO

YES

NO

Device Users, Use Environments 

and User Interface (Section 5)

Preliminary Analyses and 

Evaluations (Section 6)

Elimination or Reduction of UseRelated Hazards (Section 7)

Documentation (Section 9)
16

Human Factors of Device Use
20

Device Use

Device User Interface (adapted from Redmill and Rajan, 1997)
Human Factors Validation Testing 

(Section 8)

Define intended users, use 

environments and user 

interface

Identify use-related hazards

Identify and categorize critical 

tasks

Develop and implement risk 

mitigation/control measures

Validate use safety and 

effectiveness

Use-related 

risks 

acceptable?

New userelated risks 

introduced?

Document HFE/UE process

YES

NO

YES

NO

Device Users, Use Environments 

and User Interface (Section 5)

Preliminary Analyses and 

Evaluations (Section 6)

Elimination or Reduction of UseRelated Hazards (Section 7)

Documentation (Section 9)
22

Preliminary Analyses and 

Evaluations

• Critical tasks identification and categorization:

– Categorize the user tasks based on the severity of the 

potential harm

– Warnings, precautions and contraindications in the 

labeling should be included in the risk assessment

– Examples of risk analysis tools

• Failure mode effects analysis (FMEA)

• Fault tree analysis
23

Preliminary Analyses and 

Evaluations

• Sources of known use-related problems

– Customer complaint files, knowledge of training and 

sales staff familiar with use-related problems

– Previous HFE/UE studies 

– Current device users, journal articles, relevant 

internet sites, such as:

• FDA’s Manufacturer and User Facility Device 

Experience (MAUDE) database 

• FDA’s MedSun: Medical Product Safety Network

• CDRH Medical Device Recalls
24

Preliminary Analyses and 

Evaluations

• Analytical approaches involve review and assessment 

of user interactions with the devices 

– Task analysis

– Heuristic analysis

– Expert review

• Empirical approaches derive data from users’ 

experiences interacting with the device or device 

prototypes or mock-ups

– Contextual inquiry

– Interviews 

– Formative evaluations (e.g. cognitive walk-through, 

simulated-use testing, etc.)
Human Factors Validation Testing 

(Section 8)

Define intended users, use 

environments and user 

interface

Identify use-related hazards

Identify and categorize critical 

tasks

Develop and implement risk 

mitigation/control measures

Validate use safety and 

effectiveness

Use-related 

risks 

acceptable?

New userelated risks 

introduced?

Document HFE/UE process

YES

NO

YES

NO

Device Users, Use Environments 

and User Interface (Section 5)

Preliminary Analyses and 

Evaluations (Section 6)

Elimination or Reduction of UseRelated Hazards (Section 7)

Documentation (Section 9)
26

Elimination or Reduction of UseRelated Hazards

• Address use-related hazards by applying risk management 

strategies

– Inherent safety by design

– protective measures

– information for safety

• Design modifications are generally the most effective 

means for controlling eliminating or reducing use-related 

hazards 

• Test to assess whether mitigation strategies:

– Effectively reduced the known risks and did not introduce any 

new risks
Human Factors Validation Testing 

(Section 8)

Define intended users, use 

environments and user 

interface

Identify use-related hazards

Identify and categorize critical 

tasks

Develop and implement risk 

mitigation/control measures

Validate use safety and 

effectiveness

Use-related 

risks 

acceptable?

New userelated risks 

introduced?

Document HFE/UE process

YES

NO

YES

NO

Device Users, Use Environments 

and User Interface (Section 5)

Preliminary Analyses and 

Evaluations (Section 6)

Elimination or Reduction of UseRelated Hazards (Section 7)

Documentation (Section 9)
28

Human Factors Validation Testing

• Demonstrates that the device can be used by the 

intended users, under expected use conditions, without 

serious use errors or problems

• Testing should be designed as follows:

– The test participants represent the intended (actual) 

users of the device.

– All critical tasks are performed during the test

– The device user interface represents the final design

– The test conditions are sufficiently realistic to 

represent actual conditions of use
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Test Participants

• Test participants should represent the population of 

intended users

• In general, the minimum number of participants 

should be 15 for each distinct population; 

– examples of distinct populations: Pediatric and adult, 

Healthcare providers and lay users

• Your employees should not serve as test participants 

• The test participants should reside in the U.S. 

Exceptions to this are considered on a case-by-case 

basis.
31

Tasks and Use Scenarios

• Tasks that logically occur in sequence when using the 

device can be grouped into use scenarios

• Use scenarios in the testing should be organized to 

represent a natural workflow 

• Prior to testing, you should define user performance that 

represents success for each task 

• Critical tasks that have a low frequency of occurrence 

require careful consideration and should be included in 

the testing
32

Instructions for Use

• The labeling used in the human factors validation testing 

should represent the final designs

• The human factors validation testing can indirectly assess 

the instructions for use for the device, but only in the 

context of use of the device

• Stating that you mitigated the risks by modifying the 

instructions for use is not acceptable, unless you provide 

additional test data demonstrating that the modified 

elements were effective in reducing the risks to 

acceptable levels
33

Participant Training

• The training provided to the human factors validation test 

participants should approximate the training that actual 

users would receive

• Stating your intention to mitigate the risks by providing 

“additional training” is not acceptable unless you provide 

additional data that demonstrates that it would be 

effective in reducing the risks to acceptable levels

• Minimum one hour training decay should be included; 

longer time would be appropriate when it is necessary to 

evaluate training decay as a source of use-related risk
34

Data Collection (Objective)

• Observational data

– observations of participants’ performance of all the 

critical use scenarios (which include all the critical 

tasks) 

• Knowledge task data

– Comprehension of interface components involved in 

knowledge tasks are usually the user manual, quick 

start guide, labeling on the device itself, and training
35

Data Collection (Subjective)

• Interview data 

– Participant feedback considering the overall device and 

then focused on each critical task or use scenario

– Participant assessment of any use difficulties, 

confusions or errors that were experienced during the 

test

– Participant assessment of root cause for any observed 

or participant reported use difficulties, confusions or 

errors
36

Analysis of Human Factors 

Validation Test Results

• Analyze qualitatively by aggregating objective and 

subjective data to: 

– Identify potential use errors

– and determine the root causes

• Address use errors and problems through risk 

management strategies 

• Conduct human factors (re-)validation testing on the 

modified user interface elements 
39

Actual Use Testing

• When actual-use testing is determined to be necessary 

(rare) to ensure safe use of the proposed device, an 

Investigational Device Exemption (IDE) may be required.

– Actual-use testing can also be conducted as part of a 

clinical study. 

– it is inadequate to depend solely on self-reports data 

since these data can be incomplete or inaccurate
Human Factors Validation Testing 

(Section 8)

Define intended users, use 

environments and user 

interface

Identify use-related hazards

Identify and categorize critical 

tasks

Develop and implement risk 

mitigation/control measures

Validate use safety and 

effectiveness

Use-related 

risks 

acceptable?

New userelated risks 

introduced?

Document HFE/UE process

YES

NO

YES

NO

Device Users, Use Environments 

and User Interface (Section 5)

Preliminary Analyses and 

Evaluations (Section 6)

Elimination or Reduction of UseRelated Hazards (Section 7)

Documentation (Section 9)
42

Human Factors Recommended 

Report Outline

1. Conclusion

2. Description of Intended device users, uses, 

environments and training

3. Description of device user interface

4. Summary of known use problems

5. Analysis of risks associated with use of the device

6. Summary of preliminary analyses and evaluations

7. Description and categorization of critical tasks

8. Details of human factors validation testing
43

When to submit... 

From the 2015 HF Guidance scope:

“In an effort to make CDRH’s premarket submission 

expectations clear regarding which device types should 

include human factors data in premarket submissions, 

CDRH is issuing a draft guidance document List of Highest 

Priority Devices for Human Factors Review, Draft 

Guidance for Industry and Food and Drug Administration 

Staff. When final, this document will represent the 

Agency’s current thinking on this issue.”
44

List of Highest Priority Devices for 

Human Factors Review Draft Guidance 

• FDA is issuing this guidance document in order to inform 

medical device manufacturers which device types should 

have human factors data included in premarket 

submissions (i.e., for PMA, 510(k) and related Presubmissions). 

• For devices that should include human factors data in 

premarket submissions, as listed here, manufacturers 

should provide FDA with a human factors report
45

List of Highest Priority Device Types

• Ablation generators (associated with 

ablation systems, e.g., LPB, OAD, OAE, 

OCM, OCL)

• Anesthesia machines (e.g., BSZ) 

• Artificial pancreas systems (e.g., OZO, OZP, 

OZQ)

• Auto injectors (when CDRH is lead Center; 

e.g., KZE, KZH, NSC )

• Automated external defibrillators (e.g., 

MKJ, NSA )

• Duodenoscopes (on the reprocessing; e.g., 

FDT) with elevator channels

• Gastroenterology-urology endoscopic 

ultrasound systems (on the reprocessing; 

e.g., ODG) with elevator channels

• Hemodialysis and peritoneal dialysis 

systems (e.g., FKP, FKT, FKX, KDI, KPF, ODX, 

ONW) 

• Implanted infusion pumps (e.g., LKK, MDY)

• Infusion pumps (e.g., FRN, LZH, MEA, MRZ)

• Insulin delivery systems (e.g., LZG, OPP)

• Negative-pressure wound therapy (e.g., 

OKO, OMP) intended for use in the home

• Robotic catheter manipulation systems 

(e.g., DXX) 

• Robotic surgery devices (e.g., NAY)

• Ventilators (e.g., CBK, NOU, ONZ)

• Ventricular assist devices (e.g., DSQ, PCK)
46

How this List Should be Used for 

Premarket Submissions

• For device types on the list: Any premarket submission for 

the device types listed above should include either a 

human factors test report and data or should provide a 

detailed rationale that supports the conclusion that 

human factors data are not necessary. 
47

How this List Should be Used for 

Premarket Submissions

• For device types not on the list: ODE may also determine 

that human factors data are needed in a specific 

premarket submission on a case-by-case basis when one 

or more of the following apply:

– Submission type

– User interface modification

– Different users

– Recalls, adverse events, and problem reports

– Device modifications
48

Advice: Consult FDA Early

• Discuss product development plans with FDA before your 

design is finalized (and changes would be difficult)

• FDA encourages manufacturers to submit a draft of the 

human factors testing protocol prior to conducting the 

test. The premarket mechanism for this is a Presubmission.

 
49

Questions
50

Questions?

General questions about human factors and usability engineering 

processes? 

Contact CDRH's Division of Industry and Consumer Education (DICE) 

at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100

Questions about following appropriate human factors and usability 

engineering processes in a specific device? 

Contact CDRH Human Factors team at HFPMET@fda.hhs.gov

Slide Presentation, Transcript and Webinar Recording will be 

available at:

http://www.fda.gov/training/cdrhlearn

Under “Specialty Technical Topics” Heading