FDA可用性指南

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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: February 3, 2016

As of April 3, 2016, this document supersedes “Medical Device Use-Safety:

Incorporating Human Factors Engineering into Risk Management” issued

July 18, 2000.

The draft of this document was issued on June 21, 2011.

For questions regarding this document, contact the Human Factors Premarket Evaluation

Team at (301) 796-5580.

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Devices and Radiological Health

Office of Device Evaluation

Contains Nonbinding Recommendations

Preface

Public Comment

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

http://www.regulations.gov . Submit written comments to the Division of Dockets

Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305),

Rockville, MD 20852. 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 use the document

number 1757 to identify the guidance you are requesting.

Contains Nonbinding Recommendations

Table of Contents

Contents

Introduction __________________________________________________________ 1

Scope _______________________________________________________________ 1

3. Definitions ___________________________________________________________ 2

3.1 Abnormal use __________________________________________________________ 2

3.2 Critical task ____________________________________________________________ 3

3.3 Formative evaluation ____________________________________________________ 3

3.4 Hazard ________________________________________________________________ 3

3.5 Hazardous situation _____________________________________________________ 3

3.6 Human factors engineering _______________________________________________ 3

3.7 Human factors validation testing ___________________________________________ 3

3.8 Task __________________________________________________________________ 3

3.9 Use error ______________________________________________________________ 3

3.10 Use safety ______________________________________________________________ 3

3.11 User ___________________________________________________________________ 3

3.12 User interface___________________________________________________________ 4

4. Overview ____________________________________________________________ 4

4.1 HFE/UE as Part of Risk Management ______________________________________ 4

4.2 Risk Management _______________________________________________________ 6

5. Device Users, Use Environments and User Interface _________________________ 7

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 _________________________ 13

6.3.1 Task Analysis _____________________________________________________________ 14

6.3.2 Heuristic Analysis __________________________________________________________ 15

6.3.3 Expert Review_____________________________________________________________ 15

6.4 Empirical Approaches to Identifying Critical Tasks __________________________ 15

6.4.1 Contextual Inquiry _________________________________________________________ 16

6.4.2 Interviews ________________________________________________________________ 16

6.4.3 Formative Evaluations ______________________________________________________ 16

6.4.3.1 Cognitive Walk-Through _________________________________________________ 18

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摘要：

ContainsNonbindingRecommendationsApplyingHumanFactorsandUsabilityEngineeringtoMedicalDevicesGuidanceforIndustryandFoodandDrugAdministrationStaffDocumentissuedon:February3,2016AsofApril3,2016,thisdocumentsupersedes“MedicalDeviceUse-Safety:IncorporatingHumanFactorsEngineeringintoRiskManagement”issuedJ...

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