FDA医疗器械的人因与可用性工程应用指南_2026.03

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Contains Nonbinding Recommendations

Applying Human Factors and

Usability Engineering to Medical

Devices

Guidance for Industry and Food and

Drug Administration Staff

Document issued on August 3, 2026

Document originally issued on February 3, 2016.

For questions about this document, contact the Human Factors Engineering Team at

HFPMET@fda.hhs.gov.

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Devices and Radiological Health

Contains Nonbinding Recommendations

Preface

Public Comment

You may submit electronic comments and suggestions at any time for Agency consideration to

https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food

and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852-

1740. Identify all comments with the docket number FDA-2011-D-0469. Comments may not be

acted upon by the Agency until the document is next revised or updated.

Additional Copies

Additional copies are available from the Internet. You may also send an e-mail request to

CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document

number GUI00001757 and complete title of the guidance in the request.

Contains Nonbinding Recommendations

Table of Contents

1. Introduction ............................................................................................................................ 1

2. Scope ...................................................................................................................................... 2

3. Definitions.............................................................................................................................. 3

4. Overview ................................................................................................................................ 4

4.1 HFE/UE as Part of Risk Management ............................................................................. 5

4.2 Risk Management ............................................................................................................ 6

5. Device Users, Use Environments and User Interface ............................................................ 8

5.1 Device Users .................................................................................................................... 9

5.2 Device Use Environments.............................................................................................. 10

5.3 Device User Interface .................................................................................................... 10

6. Preliminary Analyses and Evaluations ................................................................................ 11

6.1 Critical Task Identification and Categorization ................................................................ 12

6.1.1 Failure mode effects analysis ................................................................................... 12

6.1.2 Fault tree analysis .................................................................................................... 13

6.2 Identification of Known Use-Related Problems ............................................................ 13

6.3 Analytical Approaches to Identifying Critical Tasks..................................................... 14

6.3.1 Task Analysis ........................................................................................................... 14

6.3.2 Heuristic Evaluation................................................................................................. 15

6.3.3 Expert Review .......................................................................................................... 15

6.4 Empirical Approaches to Identifying Critical Tasks ..................................................... 16

6.4.1 Contextual Inquiry ................................................................................................... 16

6.4.2 Interviews ................................................................................................................. 16

6.4.3 Formative Evaluations ............................................................................................. 16

7. Elimination or Reduction of Use-Related Hazards .............................................................. 19

8. Human Factors Validation Testing ...................................................................................... 20

8.1 Simulated-Use Human Factors Validation Testing ....................................................... 21

8.1.1 Test Participants (Subjects)...................................................................................... 21

8.1.2 Tasks and Use Scenarios .......................................................................................... 23

8.1.3 Instructions for Use .................................................................................................. 23

8.1.4 Participant Training ................................................................................................. 24

8.1.5 Data Collection ........................................................................................................ 24

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标签： #医疗器械 #指南 #可用性工程

摘要：

ContainsNonbindingRecommendationsApplyingHumanFactorsandUsabilityEngineeringtoMedicalDevicesGuidanceforIndustryandFoodandDrugAdministrationStaffDocumentissuedonAugust3,2026DocumentoriginallyissuedonFebruary3,2016.Forquestionsaboutthisdocument,contacttheHumanFactorsEngineeringTeamatHFPMET@fda.hhs.gov...

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