Contains Nonbinding Recommendations 
 
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List of Highest Priority Devices for 
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Human Factors Review
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3 ______________________________________________________________________________ 
Draft Guidance for Industry and  
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Food and Drug Administration Staff 
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DRAFT GUIDANCE
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This draft guidance document is being distributed for comment purposes only. 
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12 Document issued on February 3, 2016. 
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15 You should submit comments and suggestions regarding this draft document within 90 days of 
16 publication in the Federal Register of the notice announcing the availability of the draft 
17 guidance.  Submit electronic comments to http://www.regulations.gov.  Submit written 
18 comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 
19 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  Identify all comments with the docket 
20 number listed in the notice of availability that publishes in the Federal Register. 
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22 For questions regarding this document, contact the Human Factors Premarket Evaluation Team 
23 at (301) 796-5580. 
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26 U.S. Department of Health and Human Services 
27 Food and Drug Administration 
28 Center for Devices and Radiological Health 
29 Office of Device Evaluation  
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Preface 
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Additional Copies 
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38 Additional copies are available from the Internet.  You may also send an e-mail request to CDRH-
39 Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document number 
40 1500052 to identify the guidance you are requesting. 
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List of Highest Priority Devices for 
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Human Factors Review
 
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Draft Guidance for Industry and  
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Food and Drug Administration Staff  
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49 This draft guidance, when finalized, will represent the Food and Drug Administration's 
50 (FDA's) current thinking on this topic.  It does not create or confer any rights for or on any 
51 person and does not operate to bind FDA or the public.  You can use an alternative approach 
52 if the approach satisfies the requirements of the applicable statutes and regulations.  If you 
53 want to discuss an alternative approach, contact the FDA staff responsible for implementing 
54 this guidance.  If you cannot identify the appropriate FDA staff, call the appropriate number 
55 listed on the title page of this guidance.  
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I.  Introduction 
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59 FDA is issuing this guidance document in order to inform medical device manufacturers which  
60 device types should have human factors data included in premarket submissions (i.e., for PMA, 
61 510(k)).  FDA believes these device types have clear potential for serious harm resulting from 
62 use error, and that review of human factors data in premarket submissions will help FDA 
63 evaluate the safety and effectiveness and substantial equivalence of these devices.   
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65 FDA's guidance documents, including this draft guidance, do not establish legally enforceable 
66 responsibilities. Instead, guidances describe the Agencys current thinking on a topic and should 
67 be viewed only as recommendations, unless specific regulatory or statutory requirements are 
68 cited. The use of the word should in Agency guidance means that something is suggested or 
69 recommended, but not required.  
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II.  Background 
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72 FDA issued the guidance document, Applying Human Factors and Usability Engineering to 
73 Medical Devices, Guidance for Industry and Food and Drug Administration Staff, to assist 
74 industry in following appropriate human factors and usability engineering processes to maximize 
75 the likelihood that new medical devices will be safe and effective for the intended users, uses and 
76 use environments.   
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77 For devices that should include human factors data in premarket submissions, as listed here, 
78 manufacturers should provide FDA with a report (see Appendix A of Applying Human Factors 
79 and Usability Engineering to Medical Devices) that summarizes the human factors or usability 
80 engineering processes they have followed, including any preliminary analyses and evaluations 
81 and human factors validation testing, results and conclusions.  
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III.  List of Device Types for Which Human Factors Data 
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Should be Submitted for Review 
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86 CDRH considers human factors testing a valuable component of product development for 
87 medical devices.  CDRH recommends that manufacturers consider human factors testing for 
88 medical devices as a part of a robust design control subsystem.  However, in an effort to make 
89 CDRHs premarket submission expectations clear, CDRH has identified circumstances under 
90 which human factors validation testing should be submitted in a premarket submission.  These 
91 devices noted below were selected because they have clear potential for serious harm resulting 
92 from use error.  This identification was based on knowledge gleaned through Medical Device 
93 Reporting (MDRs) and recall information.  Human factors data should be included in premarket 
94 submissions for these devices unless the submission does not involve any changes to users, user 
95 tasks, user interface, or use environments from those of the predicates.  
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97   Ablation generators (associated with ablation systems, e.g., LPB, OAD, OAE, OCM, 
98 OCL) 
99   Anesthesia machines (e.g., BSZ)  
100   Artificial pancreas systems (e.g., OZO, OZP, OZQ) 
101   Auto injectors (when CDRH is lead Center; e.g., KZE, KZH, NSC ) 
102   Automated external defibrillators (e.g., MKJ, NSA ) 
103   Duodenoscopes (on the reprocessing; e.g., FDT) with elevator channels 
104   Gastroenterology-urology endoscopic ultrasound systems (on the reprocessing; e.g., 
105 ODG) with elevator channels 
106   Hemodialysis and peritoneal dialysis systems (e.g., FKP, FKT, FKX, KDI, KPF ODX, 
107 ONW) 
108   Implanted infusion pumps (e.g., LKK, MDY) 
109   Infusion pumps (e.g., FRN, LZH, MEA, MRZ ) 
110   Insulin delivery systems (e.g., LZG, OPP) 
111   Negative-pressure wound therapy (e.g., OKO, OMP) intended for use in the home 
112   Robotic catheter manipulation systems (e.g., DXX)  
113   Robotic surgery devices (e.g., NAY) 
114   Ventilators (e.g., CBK, NOU, ONZ) 
115   Ventricular assist devices (e.g., DSQ, PCK) 
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117 Note that FDA may recommend or require that human factors data be included in premarket 
118 submissions for additional device types though product specific guidance documents, special 
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119 controls guidance or guideline documents, or special controls contained in medical device 
120 classification regulations.  Premarket reviewers may also determine that human factors data are 
121 needed in specific premarket submissions on a case-by-case basis (see Section IV below). 
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IV.  How this List Should be Used for Premarket 
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Submissions 
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126 For device types on the list: Any premarket submission for the device types listed above should 
127 include either a human factors test report and data as described in Applying Human Factors and 
128 Usability Engineering to Medical Devices 
129 (http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm259760.p
130 df), or should provide a detailed rationale that supports the conclusion that human factors data are 
131 not necessary.  In essence, this rationale would be based on analysis of risk associated with users, 
132 uses, and use environments and results of that analysis would indicate that the severity of the 
133 potential harm resulting from use error is not serious. 
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135 For device types not on the list: Submissions for device types not on the list above should 
136 contain human factors data if analysis of risk indicates that users performing tasks incorrectly or 
137 failing to perform tasks could result in serious harm. ODE may also determine that human 
138 factors data are needed in a specific premarket submission on a case-by-case basis when one or 
139 more of the following apply: 
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141   Submission type: Premarket Application (PMA) or De Novo Petition for a device that 
142 has potential for serious harm resulting from use error 
143   User interface modification: New or different user interface features were implemented 
144 to satisfy a special control1 or recommendation (in a device-specific guidance document) 
145 related to its use 
146   Different users:  The submission includes a change of intended users, for instance the 
147 new device is intended for use by lay users when the predicates were labeled for use only 
148 by healthcare professionals and device use has potential for serious harm resulting from 
149 use error 
150   Recalls, adverse events, and problem reports: The device type has been associated 
151 with recalls, adverse events, problem reports or complaints for which the cause has been 
152 attributed to use error or use error is the only explanation 
153   Device modifications: The device was modified or differs from the predicate in any of 
154 the following ways and the device has potential for serious harm resulting from use error: 
155 o  The user interface has been modified (even if it has been simplified) 
156 o  User tasks have been added or changed 
157 o  The severity of possible harm resulting from use error has increased 
                                                           
1 Special controls are regulatory requirements for class II devices and are usually device specific.  These controls 
can include premarket data requirements. 
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158 o  The device will be used in a new use environment (e.g., in the home or a moving 
159 vehicle) 
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