Contains Nonbinding Recommendations
Draft Not for Implementation
Content of Human Factors 
Information in Medical Device 
Marketing Submissions
______________________________________________________________________________
Draft Guidance for Industry and
Food and Drug Administration Staff
DRAFT GUIDANCE
This draft guidance document is being distributed for comment purposes 
only.
Document issued on December 9, 2022.
You should submit comments and suggestions regarding this draft document within 90 days of 
publication in the Federal Register of the notice announcing the availability of the draft 
guidance. Submit electronic comments 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. Identify all comments with the docket number 
listed in the notice of availability that publishes in the Federal Register.
For questions about this document, contact OHT3: Office of Gastro-Renal, ObGyn, General 
Hospital, and Urology Devices/DHT3C: Division of Drug Delivery and General Hospital 
Devices and Human Factors at (301) 796-5580.
When final, this guidance is intended to be used to complement the FDA 
guidance Applying Human Factors and Usability Engineering to Medical 
Devices, issued February 3, 2016. After reviewing public comment on this 
draft guidance and upon its finalization, FDA intends to concurrently revise 
the Applying Human Factors and Usability Engineering to Medical Devices 
guidance, as described herein. 
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health Contains Nonbinding Recommendations
Draft Not for Implementation
Preface
Additional Copies
Additional copies are available from the Internet. You may also send an email request to CDRH-
Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document number 
1500052 and complete title of the guidance in the request. Contains Nonbinding Recommendations
Draft Not for Implementation
Table of Contents
I.  Introduction ............................................................................................................................. 1 
II.  Scope ....................................................................................................................................... 3
III.  Definitions ............................................................................................................................... 3
IV.  Risk-based approach to human factors engineering information in marketing submissions .. 5
How to determine HF Submission Category.......................................................................8
What to include in a marketing submission based on HF Submission Category................9
V.  Recommended content of human factors information in marketing submissions ................ 11
VI.  Examples ............................................................................................................................... 15
Modification to an existing 510(k)-cleared device............................................................15
Modification to an existing PMA-approved device...........................................................19
New devices.......................................................................................................................22 Contains Nonbinding Recommendations
Draft Not for Implementation
Content of Human Factors 
1
Information in Medical Device 
2
Marketing Submissions
3
4 ______________________________________________________________________________
Draft Guidance for Industry and
5
Food and Drug Administration Staff
6
7
8 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
9  Administration (FDA or Agency)on this topic. It does not establish any rights for any person 
10 and is not binding on FDA or the public. You can use an alternative approach if it satisfies the 
11 requirements of the applicable statutes and regulations. To discuss an alternative approach, 
12 contact the FDA staff or Office responsible for this guidance as listed on the title page.
13
I. Introduction1
14
15 FDA is committed to fostering the development of and patient access to innovative medical 
16 devices while balancing theirbenefits and risks. A unique aspect of medical devices is the
17 critical role of device-user interfaceinteractions for theirsafe use. Manufacturers routinely 
18 perform human factors assessments of the human-device interface during device development. 
19 This guidance provides a risk-based framework to guide manufacturers and FDA staff on the 
20 human factors information that should beincluded in a marketing submission to the Center for 
21 Devices and Radiological Health (CDRH)to facilitate the efficiency of the FDA review process.
22
23 The goal of the human factors assessment is to ensure that the device user interface has been 
24 designed such that use errors that occur during use of the device that could cause harm or 
25 degrade medical treatment are either eliminated or reduced to the extent possible. The main 
26 factors to consider ina risk-based approach to human factors assessment, as described in this 
27 draft guidance, includethe identification of (i.e., presence of or modification to) critical tasks and 
28 the elimination or reduction of use-related hazards.
29
30 This guidance includes recommendations for the content of human factors and usability 
31 engineering information to be included in marketing submissions.2 FDAs decision on a medical 
1 This guidance has been prepared by the Center for Devices and Radiological Health in cooperation with the Office 
of Combination Products at the Food and Drug Administration.
2 In the United States, the term human factors engineering is predominant but in other parts of the world, 
usability engineering is preferred. For the purposes of this document, the two terms are considered 
interchangeable.
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32 device marketing submission is based on the applicable statutory and regulatory criteria (e.g., 
33 substantial equivalence for premarket notification (510(k))submissions, reasonable assurance of 
34 safety and effectivenessfor premarket approval applications (PMAs)or De Novo classification 
35 requests (De Novo requests)). Human factors, to the extent relevant, constitute just one 
36 component of FDAs assessment. While FDA believes that it is optimal to minimize use-related 
37 risks, it may not be necessary,nor practical,to eliminate all use-related device risks.
38
39 The marketing submission should,where appropriate,demonstrate that the needs of the intended 
40 users were considered in the device design and that the device is safe and effective for the 
41 intended users, uses, and use environments. Thus, marketing submissions should include,where 
42 appropriate,information that explains the presence or absence of critical tasks, validation testing 
43 for risk mitigation strategies, and a description of residual risks. Including appropriate human 
44 factors informationmayimprove the efficiency of FDA review by reducing the number of 
45 requests for additional information.
46
47 After considering stakeholder feedback on the draft guidance List of Highest Priority Devices 
48  for Human Factors Review,3 FDA has decided that it should issue another draft guidance 
49 regarding submission of human factors information for the purposes of premarket review, which
50  will supersede the draft guidanceList of Highest Priority Devices for Human Factors Review. 
51   
52  When finalized, this draft guidance is intended to be used to complement the FDA guidance 
53  Applying Human Factors and Usability Engineering to Medical Devices4 (hereafter referred to 
54  as the Human Factors Guidance). The purpose of the Human Factors Guidance is to recommend 
55  and guide manufacturers through human factors engineering processes during the development 
56  of new medical devices, focusing specifically on the user interface. That guidance provides 
57  relevant human factors definitions and recommends useful preliminary analysis and evaluation 
58  tools and validation testing that will enable manufacturers to assess and reduce risks associated 
59  with medical device use. The purpose of the current guidance is to help manufacturers apply a 
60  risk-based approach when considering what human factors information to include in a marketing 
61 submission.
62
63  After reviewing public comment on this draft guidance and upon its finalization, FDA intends to 
64  concurrently revise the Human Factors Guidance to incorporate the definitions included in this 
65  guidance, superseding the definitions in Section 3 of the Human Factors Guidance. FDA also 
66  intends to concurrently revise the Human Factors Guidance by replacing Section 9 
67  Documentation and Appendix A Human Factors and Usability Engineering Report of the 
68  Human Factors Guidance with cross-references to Section V of this guidance,and by making 
69 any other revisions to the Human Factors Guidance as appropriate.
70
3 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/list-highest-priority-devices-human-
factors-review.
4 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-
usability-engineering-medical-devices.
2 Contains Nonbinding Recommendations
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71 For the current edition of the FDA-recognized consensus standard(s) referenced in this 
72 document, see the FDA Recognized Consensus Standards Database.5 For more information 
73 regarding use of consensus standards in regulatory submissions, please refer to the FDA 
74 guidance titled Appropriate Use of Voluntary Consensus Standards in Premarket Submissions 
75 for Medical Devices.6
76
77 FDA recognizes and anticipates that the Agencyand industry may need up to 60 days to perform 
78 activities to operationalize the policies within this guidance. If new information regarding the 
79 content of human factors information for marketing submissions is not included in a marketing 
80 submission received by FDA before or up to 60 days after the publication of the final guidance, 
81 CDRH staff does not generally intend to request such information during the review of the 
82 submission. CDRH does, however, intend to review any such information, if submitted.
83
84 In general, FDAs guidance documents do not establish legally enforceable responsibilities. 
85 Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
86 as recommendations, unless specific regulatory or statutory requirements are cited.The use of 
87 the word should in Agency guidancemeans that something is suggested or recommended, but 
88 not required.
89
II. Scope
90
91 This guidance is intended to help submitters and FDA staffdeterminewhat human factors 
92 evaluation information should be included in marketing submissions for medical devices, 
93 including 510(k)s, De Novo requests,PMAs, including PMA supplements, and humanitarian 
94 device exemption (HDE) applications.7
95
96 The guidance is not intended to inform manufacturers about how to perform a human factors 
97 evaluation. This guidance is also not intended to describe when a marketing submission should 
98 be submitted to legally market a new or modified device.
99
III. Definitions
100
101 Thefollowing definitions8 apply for the purposes of this guidance:
5 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.
6 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices.
7 For more information on the human factors evaluation of combination products, see the FDA draft guidance 
document Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and 
Development, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/human-
factors-studies-and-related-clinical-study-considerations-combination-product-design-and. When final, that 
guidance will represent FDAs current thinking on the topic thereof.
8 The definitions provided in this section are informed by, but not necessarily identical to, the definitions found in 
the sources that are cited.
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102  Abnormal use: An intentional act or intentional omission of an act that reflects 
103 violative or reckless use or sabotage beyond reasonable means of risk mitigation or 
104 control through design of the user interface.
105  Critical task: A user task which, ifperformed incorrectly or not performed at all, 
106 would or could cause serious harm to the patient or user, where harm is defined to 
107 include compromised medical care.
108   Formative evaluation: User interface evaluation conducted with the intent to explore 
109 user interface design strengths, weaknesses, and unanticipated use errors.9
110  Harm:Injury or damage to the health of people, or damage to property or the 
111 environment.10
112    Hazard: Potential source of harm.11  
113    Hazardous situation: Circumstance in which people, property or the environment 
114  is/are exposed to one or more hazards.12  
115    Human factors engineering: Application of knowledge about human behavior, 
116  abilities, limitations, and other characteristics to the design of medical devices 
117  (including software), systems and tasks to achieve adequate usability.13  
118    Human factors validation testing: Testing conducted at the end of the device 
119  development process to assess user interactions with a device user interface to 
120  identify use errors that would or could result in serious harm to the patient or user. 
121 Human factors validation testing is also used to assess the effectiveness of risk 
122 management measures. Human factors validation testing represents one portion of 
123 design validation.
124  Normal use: Operation, including routine inspection and adjustments by any user, 
125 and stand-by, according to the instructions for use or in accordance with generally 
126 accepted practice for those medical devices provided without instructions for use.14
127  Residual risk: Risk remaining after risk control measures have been implemented.15
128  Serious harm: Includes both serious injury and death.
129  Serious injury: An injury or illness that is life-threatening, results in permanent 
130 impairment of a body function or permanent damage to a body structure, or 
131 necessitates medical or surgical intervention to preclude permanent impairment of a 
132 body function or permanent damage to a body structure. Permanent means 
9 ANSI/AAMI/IEC 62366-1:2015+AMD1:2020 Medical devicesPart 1: Application of usability engineering to 
medical devices. Formative evaluation is generally performed iteratively throughout the design and development 
process, but prior to summative evaluation, to guide user interface design as necessary.
10 ANSI/AAMI/ISO 14971 Third Edition 2019-12 Medical devicesApplication of risk management to medical 
devices.
11 ANSI/AAMI/ISO 14971 Third Edition 2019-12 Medical devicesApplication of risk management to medical 
devices. 
12 ANSI/AAMI/ISO 14971 Third Edition 2019-12 Medical devicesApplication of risk management to medical 
devices.
13 ANSI/AAMI/IEC 62366-1:2015+AMD1:2020 Medical devicesPart 1: Application of usability engineering to 
medical devices.
14 Ibid.
15 ANSI/AAMI/ISO 14971 Third Edition 2019-12 Medical devicesApplication of risk management to medical 
devices.
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133 irreversible impairment or damage to a body structure or function, excluding trivial 
134 impairment or damage.16
135  Task: One or more user interactions with a medical device to achieve a desired 
136 result.17
137   Use environment: Actual conditions and setting in which users interact with the 
138  medical device.18 
139    Use error: User action or lack of action that was different from that expected by the 
140 manufacturer and caused a result that (1) was different from the result expected by the 
141 user and (2) was not caused solely by device failure and (3) did or could result in 
142 harm.
143    Use safety: How safe a device is when used or the extent to which risks of harm 
144 resulting from use error formedical devices have been either reduced to an acceptable 
145 level or eliminated completely.
146    User: Person interacting with (i.e., operating or handling) the medical device.19  
147    User interface: Means by which the user and the medical device interact.20 
148    Use-related risk: Combined probability, occurrence, and severity of harm for a given 
149  aspect of device use or for the overall use of a device.21 
150    Use-related risk analysis: Systematic use of available information to identify use-
151  related hazards and to estimate the use-related risk. 
152   
IV.  Riskbased approach to human factors engineering 
153 
information in marketing submissions 
154 
155  The purpose of including human factors engineering information in a marketing submission is to 
156  help the manufacturer meet the applicable legal standard by demonstrating that the user interface 
157  of the device is appropriate for the intended users, uses, and use environments. This section uses 
158  flowcharts, tables, and text to guide submitters through a risk-based approach to recommend 
159  what human factors engineering information a submitter should include in their marketing 
160 submission. 
161
162  FDA refers to this risk-based approach as the Human Factors (HF) Submission Category. 
163 Submitters should use the flowchart in 
164  Figure 1 and use its companion text to answer the questions posed at each decision point to 
165 determine which HF Submission Category is appropriate to support their marketing submission.
16 See 21 CFR 803.3(w).
17 ANSI/AAMI/IEC 62366-1:2015+AMD1:2020  Medical devicesPart 1: Application of usability engineering to 
medical devices.
18 Ibid.
19 ANSI/AAMI/IEC 62366-1:2015+AMD1:2020 Medical devicesPart 1: Application of usability engineering to 
medical devices.
20 ANSI/AAMI/IEC 62366-1:2015+AMD1:2020 Medical devicesPart 1: Application of usability engineering to 
medical devices. Examples include packaging, labeling, training materials, physical controls, display elements, 
alarms, and logic of operation of each device component.
21 ANSI/AAMI HE75:2009/(R)2018: Human factors engineering - Design of medical devices.
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166  This flowchart is based on the devices indications for use and the use-related risk analysis in the 
167 context of new devices and devices for which FDA has granted marketing authorization. 
168
169  FDA based the HF Submission Categories on the presence of or modification to critical tasks, 
170  considering changes to technological characteristics or the indications for use, if relevant. 
171  Submitters should use the use-related risk analysis and the decision points described below to 
172  help determine the HF Submission Category for their marketing submission. Submitters should 
173  also reference Table 1 for FDAs recommended human factors engineering information to 
174  provide in a marketing submission after they determine which HF Submission Category their 
175 submission falls under using 
176 Figure 1. 
177
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178 
A. Is it a modification to Reminder: Flowcharts are
an existing device? provided as a visual aid, but
do not capture all appropriate
considerations. Refer to
Yes
accompanying text when
using this flowchart.
B. Is there a change 
to any of the following:
 User interface; HF Submission Category 1. 
No  Intended device users; No Provide conclusion and high-level 
 Intended device uses; summary of HF evaluation.
 Intended use environment(s);
 Training; or 
 Labeling?
Yes
HF Submission Category 2.
Provide rationale in submission 
for why:
C. Based on the use-
 New devices only: There are
related risk analysis, are there:
no critical tasks.
 New devices only: Critical tasks?
No  Modified devices only: 
 Modified devices only: New 
There are no new critical 
critical tasks introduced or are 
tasks introduced and/or no
existing critical
changes that impact critical 
tasks impacted?
tasks.
Yes
HF Submission Category 3. 
Provide a human factors engineering report that 
includes validation testing addressing:
 New devices only: Critical task(s).
 Modified devices only: New critical task(s) 
introduced or existing critical task(s) 
impacted by change.
179 
180  Figure 1. Flowchart illustrating a risk-based approach to determine the HF Submission 
181  Category. 22
182 
22 Please note that, for the purposes of this flowchart, labeling and training have been separated out from user 
interface in Decision Point B to ensure that these important aspects of the user interface are considered during the 
decision-making process.  As stated previously, this guidances definition of user interface aligns with that of 
ANSI/AAMI/IEC 62366-1 which includes labeling and training as subsets of the user interface. 
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How to determine HF Submission Category
183
184 Decision Point A: Is it a modification to an existing device? 
185 Submitters should answer Yes to this question when their submission is for a change to a 
186 device that has already receivedmarketing authorization from FDA through a 510(k), PMA, 
187 HDEapplication, or De Novo request. Submitters should generally answer No if their device is 
188 a completely new device that has not receivedmarketing authorization from FDA.Depending on 
189 specific facts and circumstances, submitters may be able to answer Yes to this question when 
190 they are proposing to apply human factors information from one of their own legally marketed 
191 devices to a subject device that has the same or a similar user interface.
192 Decision Point B: Is there a change to any of the following:
193    User interface; 
194    Intended device users; 
195    Intended device uses; 
196    Intended use environment(s); 
197    Training; or 
198    Labeling?  
199   
200  This question applies to only modified devices and is intended to assess whether there have been 
201  any proposed changes that affect the human factors assessment. If the answer to this question is 
202  No, then the level of information would fall into HF Submission Category 1; however, if the 
203 answer is Yes, then the submitter should proceed to Decision Point C.
204 Decision Point C: Based on the use-related risk analysis, are there:
205  Newdevices only: Critical tasks?23
206  Modified devices only:New critical tasks introduced or are existing critical tasks 
207 impacted?
208
209 The use-related risk analysis incorporating risk analysis approaches such as Failure Mode and 
210 Effects Analysis (FMEA), analysis of known use problems, and formative evaluation should be 
211 referencedto answer this question.24 For modified devices, FDArecommends that submitters
212 consider the use-related risk analysis on the final finished device and not just modifications to 
213 the device. This recommendation is intended to provide a holistic assessment of any critical tasks 
214 that could be impacted upstream or downstream from the altered device-user interface 
215 component.
216
23 For more information on how FDA recommends identifying and categorizing user tasks, leading to a list of 
critical tasks, see the FDA guidance document Applying Human Factors and Usability Engineering to Medical 
Devices, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-
human-factors-and-usability-engineering-medical-devices.
24 For more information on how FDA recommends using risk analysis approaches, analysis of use problems, and 
formative evaluation, see the FDA guidance document Applying Human Factors and Usability Engineering to 
Medical Devices, available at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/applying-human-factors-and-usability-engineering-medical-devices.
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217  Each identified critical task should be connected to the use-related risk analysis. When 
218  determining if a critical task has been affected by a change to the device-user interface, we 
219  recommend considering if those changes influence the cognitive and/or visual perception or the 
220  physical interaction between the user and the device. A reduction or increase in the steps to 
221 execute a critical task may be considered as affecting the critical task. 
222
223  If there are no critical tasks for a new device, or no new critical tasks introduced, and no 
224  impacted critical tasks for a modified device based on the use-related risk analysis, the answer to 
225 this question is No, and the level of information would fall into HF Submission Category 2.
226
227 If the answer is Yes, then the level of information would fall into HF Submission Category 3. 
228
What to include in a marketing submission based on HF 
229
Submission Category
230
231 Using the flowchart in 
232  Figure 1 and its companion text to determine the HF Submission Category, manufacturers 
233 should include the following human factors information in marketing submissions:
234
235  HF Submission Category 1. Provide conclusion and high-level summary of HF evaluation: 
236  The submission should include a statement justifying that the device modifications do not affect 
237  the human factors considerations of the modified device and leverage, if applicable, previous 
238  human factors engineering evaluations to provide the conclusion and high level summary. See 
239 Table 1 for the suggested submission content for devices that fall into HF Submission Category 
240 1.
241
242  HF Submission Category 2. Provide rationale in submission for why: there are no critical 
243  tasks (new devices only); or there are no new critical tasks introduced and/or no changes 
244  that impact critical tasks (modified devices only): The submitter should submit a rationale that 
245  clearly describes the basis of their decision that there are no critical tasks for a new device, or no 
246  new critical tasks introduced, and no impacted critical tasks for a modified device. This rationale 
247  should be based on the decision-making noted in Section IV.A that takes the submitter through 
248  each decision point. See Table 1 for the suggested submission content for devices that fall into 
249 HF Submission Category 2.
250
251  HF Submission Category 3. Provide a human factors engineering report that includes 
252  validation testing addressing: critical task(s) (new devices only; see Table 2); or new critical 
253  task(s) introduced or existing critical task(s) impacted by change (modified devices only; 
254  see Table 3): A comprehensive human factors engineering report that includes all elements of a 
255  human factors engineering report described in Section IV of this guidance should be submitted to 
256  FDA for marketing submissions in HF Submission Category 3. Please note that if critical tasks 
257  are impacted for a modified device, but existing risk control measures remain acceptable, you 
258 should provide your rationale in your submission as part of the human factors information.
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259
260 Table 1. Recommended minimum human factors information that should be provided for a 
261 marketing submission based on HF Submission Category
Recommended information HF Submission 
(Report section numbers from Section V below) Category
1 2 3
Conclusion and high-level summary (Section 1) u  u  u 
Descriptionsof:
  Intended device users, uses, use environments, and training 
(Section 2) u u
 Device-user interface (Section 3)
 Summary of knownuse problems (Section 4)
Preliminary activities
u
 Summary of preliminary analyses and evaluations (Section 5)
Use-related risk analysis
 Analysis of hazards and risks associated with use of the device 
u
(Section 6)
 Identification and description of critical tasks (Section 7)
Details of validation testing of final design (Section8) u
262
263 Table 2.Example tabular format for the use-related risk analysis
Use- User  Possible use  Potential  Severity  Critical  Risk  Validation method 
related  Task error(s) hazards and  of harm Task  Mitigation  for effectiveness of 
risk  clinical harm (Y/N) Measure(s)25 risk mitigation 
analysis  measure26
Task #
Task #1
Task #2
264
25 For example, such risk mitigation measures could include user interface design features, labels, instructions for 
use, or training.
26 For example, such validation methods could include human factors testing or simulated use scenario.
    
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265 Table 3. Example tabular format for the comparative use-related risk analysis
ExistingDevice Modified Device
Potential  Comparison of  Submitters 
Comparison of  Labeling 
Possible  hazards  Critical  proposed risk 
URRA  User  Severity  use task  content and/or  comparison 
use  and  task  mitigation 
Task #  Task  of harm   description to  design change  comments 
error(s)  clinical  (Y/N)  measure to 
existing device  differences 
harm  existing device 
Task 
#1                            
Task 
#2
266
V. Recommended content of human factors information in 
267
marketing submissions
268
269 A manufacturers internal documentation of risk management, human factors engineeringtesting 
270 (when applicable), and design optimization processes can help provideevidence,where 
271 appropriate,that the needs of the intended users were considered in the design and that the device 
272 is safe and effective for the intended users, uses, and use environments. The Quality System 
273 Regulation (21 CFR part 820) requires that manufacturers of certain finished devicesverify and 
274 validate device design, review and approve changes to device design, and document changes and 
275 approvals in the design history file (21 CFR 820.30). FDA recommends that human factors 
276 information be maintained by the manufacturer regardless of whether it is submitted to FDA.
277 Manufacturers must keep recordsto the extent required under applicable law, including the 
278 Quality System Regulation (e.g., 21 CFR 820.30(j)),and these(and other)records mustgenerally
279 be made available to an FDA investigator upon request (see section 704(e) of the Federal Food, 
280 Drug, and Cosmetic Act).
281
282 This section describes the HF information that may be appropriate for submission to FDA in a 
283 marketing submission when one is required.27 Thishuman factors engineeringinformation
284 describes how the human factors engineeringprocess was applied during the development of a 
285 medical device. Human factors engineering information should summarize the evaluations 
286 performed. Such information does not typically include all raw data from a human factors 
27 This guidance is not intended to address whether or not a 510(k) or a PMA supplement is required for changes 
that may involve a human factors engineering analysis. Manufacturers should apply the applicable regulatory criteria 
in 21 CFR 807.81 or 21 CFR 814.39 to determine whether a 510(k) or PMA supplement should be submitted. For 
more information, see the FDA guidances Deciding When to Submit a 510(k) for a Change to an Existing Device, 
available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-
510k-change-existing-device, Deciding When to Submit a 510(k) for a Software Change to an Existing Device, 
available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-
510k-software-change-existing-device, or Modifications to Devices Subject to Premarket Approval (PMA) - The 
PMA Supplement Decision-Making Process, available at https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/modifications-devices-subject-premarket-approval-pma-pma-supplement-decision-making-
process.
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287 validation test. The information should discuss the safety-related human factors engineering 
288 considerations, processes, issues, resolutions, and conclusions. The information should describe 
289 the identification, evaluation, and final assessment of all use-related hazards from using the 
290 device. 
291
292 Documents or analyses that are part ofthe human factors engineeringprocess should be included 
293 in the human factors engineeringinformation provided in a marketing submission. This includes 
294 portions of risk analyses focusing on user interactions with the device and specific risk analysis 
295 processes, results, and conclusions. Such information can also reference materials relevant to the 
296 human factors engineeringprocess in otherparts of the submission. A recommended structure 
297 for this human factors engineeringinformation is further described below:
298
299 Section 1: Conclusion and high-level summary 
300 Submitters should begin with a conclusion stating whether the user interface of the device has 
301 been found to be adequately designed for the intended users, uses, and use environments and 
302 whether new human factors testing was conducted to support this conclusion. FDA recommends 
303 that submitters begin with a high-level summary of thehuman factors engineeringassessment 
304 (e.g., use-related risks), including the underlying rationale for conducting the assessment, and a 
305 summary of the human factors engineeringprocesses conducted (e.g., human factors engineering
306 analyses and evaluations, device-user interface modifications and validation testing) and analysis 
307 of the results. 
308 When applicable, this section should discuss any remaining residual use-related risks after 
309 human factors validation testing. Submitters should describe why further risk mitigation is not 
310 practicablebased on a benefit-risk analysis28 forthe device.
311
312 Section 2: Descriptions of intended device users, uses, use environments, and training
313 This section should include:
314   A description of the intended user population. If there is more than one distinct user 
315  population, each population should be described. The description should include 
316  meaningful differences in capabilities or use responsibilities between user populations 
317  that could affect their interactions with the device. This includes lay and healthcare 
318  professional users who might use the same device to perform different tasks or 
319 different types of professionals who might perform different tasks on the device;
320  A summary of the devices intended use;
321   A summary of the devices operational context of use and critical aspects of device 
322 operation, including:
323   Whether users should or must be trained by a healthcare professional prior to 
324 device use;
325  How the device is used across clinical applications; and
326  Set up, maintenance, cleaning, and reprocessing information.
28 For the purposes of this guidance, FDA uses the term benefit-risk analysis consistent with ANSI/AAMI/ISO 
14971: 2019 Medical devicesApplication of risk management to medical devices.
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327   A summary of the intended use environments (e.g., hospital, medevac vehicle, home 
328  use) and the characteristics of those environments (e.g., glare, vibration, ambient 
329 noise, high levels of activity) that could affect user interactions with the device; and
330   A description of any training users would receive. A sample of the training materials 
331 such as a video, presentation slides, or a pamphlet may be appended.
332
333 Section 3: Description of device-user interface
334 When applicable, this section should include:
335   A graphical representation (e.g., photographs, illustrations, line drawings) of the 
336  device and its user interface. This should depict the overall device and all components 
337  of the user interface with which the user will interact (e.g., display and function 
338  screens, alarm speakers, controls, keypads, dedicated buttons, doors, components to 
339 be connected, retaining clips);
340  A written description of the device user interface;
341   A copy of the labeling that will be provided to the user with the device (e.g., 
342 instructions for use, user manual, quick-start guides, packaging);
343   An overview of the operational sequence of the device and the users expected 
344  interactions with the user interface. This should include the sequence of user actions 
345 performed to use the device and resulting device responses, when appropriate; and
346   For modified devices, consider providing information comparing the subject and 
347 existing devices (see Table 4 for an example format).
348
349  Table 4. Example tabular format for the comparison of the modified device user interface 
350 to the existing device
Image of existing  Image of modified  Description of the 
Modification description device-user interface  device-user  modification made to 
component interface component the modified device
Modification #1
Modification #2
351
352 Section 4: Summary of known use problems
353  This section should describe all known use problems for previous models of the same device (as 
354  applicable) or with similar types of devices (e.g., predicate devices). FDA recommends that 
355  submitters state that there are no known use problems, if applicable. For a device that has been 
356  modified specifically in response to use problems in the field, this section should discuss those 
357 problems and the device modifications.
358
359 Section 5: Summary of preliminary analyses and evaluations
360  This section should identify the preliminary analysis and evaluation methods used (e.g., specific 
361  analysis techniques, formative evaluations), summarize the key results of those analyses and 
362  evaluations, describe modifications made to the user interface design in response, and discuss the 
363 key findings that informed the protocol development for the human factors validation test.
364
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365 Section 6: Analysis of hazards and risks associated with use of the device
366 This section should include the use-related risk analysisdocument and/or comparative task 
367 analysis, as applicable. This is typically an excerpt from the comprehensive risk analysis that 
368 contains all use-related hazards and risks identified through the preliminary analyses and 
369 evaluations, including those associated with potential use errors. The use-related risk analysis 
370 document is intended to be a living document; updates should be made to identified risks and 
371 hazards throughout the device design process. FDA believes it can be useful to organize this 
372 information in a tabular format. An example tabular format is provided in Table 2. This example 
373 provides the recommended minimum information to evaluate the use-related risks associated 
374 with your device. For modified devices in HF Submission Category 3, the submitter should
375 provide a comparative task analysis (see example tabular format inTable 3)comparing the 
376  modified device use-related risk analysis with the existing device use-related risk analysis. 
377   
378  If you determine that a device change resulting in a modification to any task, associated harm, 
379  and/or risk mitigation measure does not merit new HF validation test data to support the devices 
380  use safety, please provide a rationale.  
381   
382  Section 7: Identification and description of critical tasks 
383  This section should: 
384    Explain the process followed to identify the critical tasks based on the use-related risk 
385  analysis document. Since critical tasks are determined by the severity of the potential 
386  harm, FDA recommends that the submitter describe the levels of severity being used 
387  and use a reference when appropriate. For example, if the submitter is using a 
388  qualitative five-level severity rating from a voluntary consensus standard (e.g., ISO 
389  1497129), this section should include a table of severity levels with descriptions of 
390  each level and reference the applicable standard; and 
391    List and describe the critical tasks. For HF Submission Category 3, the submitter 
392  should provide a separate table highlighting the new critical tasks if relevant and 
393  rationale for why the task does not merit new HF validation test data to support the 
394  devices use safety. The submitter should also describe each use scenario included in 
395 the human factors validation testing and list the critical and non-critical tasks that 
396 constituteeach use scenario.
397
398 When modifying an existing device, FDA recommends that submitters compare the new device 
399 user interface to their own existing device in their marketing submission. FDA recommends 
400 completing this comparison in a tabular format. An example tabular format is provided in Table 
401 4. In addition to the use-related risk analysis document for the entire device, submitters should 
402 include a subset of the use-related risk analysis that isolates tasks and risks associated with the 
403 proposed modifications made to the device. FDA recommends including photographic images of 
404 the device-user interface components that were modified, including modifications to labeling 
405 such as warning statements in an instructional manual. Submitters should list any critical tasks 
406 affected by the modification(s). Submitters should also discuss whether the risk associated with 
407 the modification is acceptable and assess whether the proposed changes warranted human factors 
29 ANSI/AAMI/ISO 14971: Medical devicesApplication of risk management to medical devices.
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408 validation testing. As stated in the Human Factors Guidance,30 the validation test may be limited 
409 to assessment of those aspects of users interactions and tasks that were affected by the design 
410 modifications.
411
412 Section 8: Details of HF validation testing of final design
413 This section should summarize all HFvalidation activities conducted. In addition to test results, 
414 this section should have a comprehensive analysis of all use errors and problems that occurred 
415 that could have resulted in harm in real-world use, a description of all design modifications made
416 to the user interface in response to the test results, and a benefit-risk discussion. A full test 
417 protocol and a sample of all scripts and forms used in the testing should be appended. Submitters 
418 should provide a residual risk analysis and the rationale for why existing mitigation controls are 
419 acceptable. While elimination of all residual risks may not be practicable, submitters should have 
420 evidence of a systematic analysis of use errors and mitigations of use-related risks.31 Submitters 
421 should reevaluate risk control and mitigation measures to identify other means to reduce risk 
422 when it is determined that the residual risks are unacceptable.
423
VI. Examples
424
425 The following are hypothetical examples of scenarios intended to illustrate FDAs risk-based 
 
426  approach to determinethe HF Submission Category using the flowchart in 
427  Figure 132 and its companion text. Based on the HF Submission Category, FDAs recommended 
428 HF information to support the marketing submission is outlined for each scenario. These 
429 examples do not account for every submission type nor the human factors information that may 
430 be appropriatefor every situation. Additionally, theexamples describing modifications to an 
431 existing device are based on an assumption that a manufacturer has already determined that it 
432 needs to submit a new marketing submission. Therefore, these examples are not intended to 
433 interpret when a new marketing submission is required. In addition, these examples are not 
434 intended to comprehensively represent what should be included in a marketing submission for a 
435 new or modification to an existing device. 
436
Modification to an existing 510(k)cleared device
437
438 Example A.1.
439 Scenario:A submitter currently has marketing authorization for a gastrointestinal lesion 
440 software detection system33 in a cleared 510(k). The device is a computer-assisted detection 
441 device used in conjunction with endoscopy for the detection of abnormal lesions in the 
30 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-
usability-engineering-medical-devices.
31 For example, see Appendix C of Applying Human Factors and Usability Engineering to Medical Devices.
32 Please refer to footnote 20 for clarification on why labeling and training are listed separately from user interface 
for the purposes of this flowchart. 
33 Gastrointestinal lesion software detection systems are classified under 21 CFR 876.1520 and are subject to the 
special controls established in the reclassification order, available at 
https://www.accessdata.fda.gov/cdrh_docs/pdf20/DEN200055.pdf.  The publication of this classification in the 
Federal Register and codification in the Code of Federal Regulations is currently pending.
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442  gastrointestinal tract. The submitter has proposed to modify the computer-assisted detection 
443  algorithm such that a new 510(k) was submitted. The algorithm modifications improve the 
444  systems ability to assist in detection of lesions and does not change any aspects of the 
445 device-user interface.
446 Decision Point A: Is it a modification to an existing device?
447  Yes. The submitter is modifying their own existing 510(k)-cleared device and using that 
448  device as the predicate device. 
449   
450 Decision Point B: Is there a change to any of the following:
451  User interface;
452  Intended device users;
453  Intended device uses;
454  Intended use environment(s);
455  Training; or
456  Labeling?
457  No. The changes to the algorithm do not impact any aspect of the device-user interface. The 
458  intended users, uses, and use environments remain the same and in this instance, changes to 
459 the algorithm do not include modifications to the labeling or training programs.
460
461  Analysis: The recommended HF information in this marketing submission is defined by HF 
462  Submission Category 1. The submitter should include a statement justifying that the device 
463  modifications do not affect the human factors considerations of the modified device and the 
464 conclusion and high level summary of HF evaluation. 
465
466 Example A.2.
467  Scenario: A submitter currently has marketing authorization for a gas machine for anesthesia 
468  in a cleared stand-alone device 510(k) submission. The gas machine for anesthesia is 
469  intended for use in the hospital environment and includes a touch screen graphical user 
470  interface (GUI) and control knobs to regulate gas flow. The submitter requests 510(k)-
471  clearance for a modification to the internal gas valving system and included in their 510(k) 
472  labeling changes to reflect the modification. There are no changes to the apparent flow 
473  settings from this internal change. Any modifications regarding calculated flow rates are 
474 made in software settings. 
475 Decision Point A: Is it a modification to an existing device?
476  Yes. The submitter is modifying their own existing 510(k)-cleared device and using that 
477 device as the predicate device.
478 Decision Point B: Is there a change to any of the following:
479  User interface;
480  Intended device users;
481  Intended device uses;
482  Intended use environment(s);
483  Training; or
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484  Labeling?
485  Yes. The labeling (instructions manual) was changed to describe the modification to the 
486  internal gas valving system. This change does not impact any external user interface 
487  component on the device itself. There are no changes to the intended device users, uses, 
488  intended use environment, or training because there are no such changes to the indications 
489 for use. 
490 Decision Point C: Based on the use-related risk analysis, are there:
491  New devices only: Critical tasks? 
492   Modified devices only: New critical tasks introduced or are existing critical 
493 tasks impacted? 
494  No. Even though the labeling (instructions manual) has changed, this change does not impact 
495  how the intended user is expected to interact with the device because the user is not intended 
496  to directly interact with the gas valving system, since it is an internal component. There are 
497  no changes that influence the cognitive and/or visual perception or the physical interaction 
498  between the user and the device. Therefore, there are no new critical tasks introduced, nor are 
499 existing critical tasks impacted. 
500
501  Analysis: The recommended HF information in this marketing submission is defined by HF 
502  Submission Category 2. The submitter should provide a rationale that clearly describes the 
503  basis of their decision that there are no new critical tasks introduced, and no impacted critical 
504 tasks for their modified device. 
505
506 Example A.3.
507  Scenario: In addition to the change described in Example A.2, the submitter also requests 
508  510(k) clearance to change the font size from 12 to 14 point on the text displayed on the 
509  graphical user interface (GUI) of the gas machine for anesthesia, along with a proportional 
510  increase in the screens physical size. The submitter is also making associated software 
511  changes to address the proposed change in the font size. The GUI menu does not change in 
512 terms of selection layout and contains the same icons representing different intended actions.
513 Decision Point A: Is it a modification to an existing device?
514  Yes. The submitter is modifying their own existing 510(k)-cleared device and using that 
515 device as the predicate device.
516 Decision Point B: Is there a change to any of the following:
517  User interface;
518  Intended device users;
519  Intended device uses;
520  Intended use environment(s);
521  Training; or
522  Labeling?
523  Yes. There are changes to the user interface from the software changes because the user is 
524 intended to directly interact visually with the words on the touch screen GUI, which the 
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525  submitter states is the only part of the device being modified. There are no changes to the 
526 intended device users, uses, intended use environment, training, or labeling. 
527 Decision Point C: Based on the use-related risk analysis, are there:
528  New devices only: Critical tasks? 
529   Modified devices only: New critical tasks introduced or are existing critical 
530 tasks impacted? 
531  No. Even though the user interface (GUI) was changed to include larger text font and a larger 
532  screen display, this change does not impact how the intended user is expected to interact with 
533  the device because the same textual information is being presented in the same layout and 
534  format. The text size change was assessed to introduce no negative influence on the cognitive 
535  and/or visual perception or the physical interaction between the user and the device. In this 
536  case, the submitter can choose to provide formative data and/or literature supporting this 
537  conclusion. Therefore, there are no new critical tasks introduced, nor are existing critical 
538 tasks impacted.
539
540  Analysis: The recommended HF information in this marketing submission is HF 
541  Submission Category 2. The submitter should provide a rationale (e.g., analysis of a 
542  literature review for acceptable font size) that clearly describes the basis of their decision that 
543  there are no new critical tasks introduced, and no impacted critical tasks for their modified 
544 device.
545
546 Example A.4.
547  Scenario: The submitter requests to change the GUI of the gas machine for anesthesia 
548  described in Example A.2. The proposed changes consist of changing textual menu selection 
549  items to icons (i.e., graphics). In addition, the submitter requests a change from the physical 
550  knob interface with discrete values for gas flow control to a digital slider with continuous 
551  values within a pre-specified range that became an added feature to the touch screen GUI. 
552  Based on these changes, the submitter updated the labeling, including the user manual and 
553 instructions for use, and training.
554
555 Decision Point A: Is it a modification to an existing device?
556  Yes. The submitter is modifying their own existing 510(k)-cleared device and using that 
557 device as the predicate device.
558 Decision Point B: Is there a change to any of the following:
559  User interface;
560  Intended device users;
561  Intended device uses;
562  Intended use environment(s);
563  Training; or
564  Labeling?
565  Yes. There are changes to the user interface because the user directly interacts visually with 
566  the icons and controls on the touch screen GUI. There is also a change in the way the user 
567 controls the gas flow. There are no changes to the intended device users, uses, or intended 
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568  use environment. Both the submitters training and labeling have changed based on the 
569 changes to the touch screen GUI. 
570 Decision Point C: Based on the use-related risk analysis, are there:
571  New devices only: Critical tasks? 
572   Modified devices only: New critical tasks introduced or are existing critical 
573 tasks impacted? 
574  Yes. There are several critical tasks associated with the main touch screen GUI of the gas 
575  machine for anesthesia, such as setting the ventilation mode, setting tidal volume and 
576  inspiratory pressure, and setting alarms. Changing the GUI to include only icons instead of 
577  text for menu selections may impact the ability of the user to comprehend the correct 
578  selection. There are also critical tasks associated with setting and controlling the gas flow to 
579  the patient. The interface for gas flow control changed from a physical knob to a digital slider 
580  on the touch screen interface, which impacts the physical interaction the user might have 
581  with the gas flow control. Although the same information is being conveyed, it is displayed 
582 in a different layout and format compared to the predicate.
583
584  Analysis: This requested change would be considered HF Submission Category 3. The 
585  submitter should submit test results and analysis from a new HF validation study for the 
586  subject device in an HF Report. The HF Report should include the use-related risk analysis, 
587 along with the information referenced in Table 3.
588
Modification to an existing PMAapproved device 
589 
590  Example B.1.  
591  Scenario: An implantable infusion pump has a physician programmer and both have been 
592  approved as a standalone device through the PMA process. The approved physician 
593  programmer is a personal digital assistant (PDA) device, with a monochrome screen and 
594  physical buttons to control scrolling and menu selection. The submitter requests approval in a 
595  PMA Supplement for a modification to the reservoir volume of the infusion pump. This 
596  proposed change does not result in any change to medication concentration or dosing 
597  calculation. The software is being updated to allow for the proposed volume change. The 
598  proposed modifications, including the software changes, have no direct effect on the device 
599 with which a physician or patient directly interact. 
600 Decision Point A: Is it a modification to an existing device?
601 Yes. The submitter is modifying their own existing PMA-approved device.
602
603 Decision Point B: Is there a change to any of the following:
604  User interface;
605  Intended device users;
606  Intended device uses;
607  Intended use environment(s);
608  Training; or
609  Labeling?
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610  Yes. The labeling (instructions manual) was updated to specify the change in the reservoir 
611 volume.
612 Decision Point C: Based on the use-related risk analysis, are there:
613  New devices only: Critical tasks? 
614   Modified devices only: New critical tasks introduced or are existing critical 
615 tasks impacted? 
616  No. There are critical tasks that could in some circumstances be impacted by a change in the 
617  reservoir volume, including medication concentration and the dosing that are related to drug 
618  delivery to the patient. In this case, the medication concentration and dosing remained the 
619  same, even with the change in reservoir volume. Therefore, no critical tasks were impacted 
620 by the change in reservoir volume.
621
622  Analysis: The recommended HF information in this marketing submission is HF 
623  Submission Category 2. The submitter should provide a rationale (e.g., discussion of how 
624  the change in total reservoir volume does not affect critical tasks such as setting 
625  concentration or calculating dosage) that clearly describes the basis of their decision that 
626  there are no new critical tasks introduced, and no impacted critical tasks for their modified 
627 device. 
628
629 Example B.2.
630  Scenario: Like 0, an implantable infusion pump has a physician programmer and both have 
631  been approved through the PMA process. The approved physician programmer is a PDA 
632  device, with a monochrome screen and physical buttons to control scrolling and menu 
633  selection. The submitter requests approval in a PMA Supplement for a modification to the 
634  physician programmer from the approved monochrome PDA to a mini-tablet computer with 
635  a touch screen user interface. The display on the tablet computer will feature a full color 
636 display and new icons for menu functions. 
637 Decision Point A: Is it a modification to an existing device?
638 Yes. The submitter is modifying their own existing PMA-approved device. 
639
640 Decision Point B: Is there a change to any of the following:
641  User interface;
642  Intended device users;
643  Intended device uses;
644  Intended use environment(s);
645  Training; or
646  Labeling?
647  Yes. The introduction of new icons, color selection and display, and new menu orientation, 
648  has changed the user interface. Due to these changes, the submitter is also proposing to 
649 change the relevant training and labeling (instructions manual).
650
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651 Decision Point C: Based on the use-related risk analysis, are there:
652  New devices only: Critical tasks? 
653   Modified devices only: New critical tasks introduced or are existing critical 
654 tasks impacted? 
655  Yes. In this case, the submitter evaluated the existing critical tasks, and some were impacted. 
656  Dose calculation function is impacted by additional (new) icon access on new home screen 
657  for unit selection and confirmation. Additional steps and workflow with new icon could 
658 cause user negative transfer of experience and lead to delay of therapy.
659
660  Analysis: The recommended HF information in this marketing submission is HF 
661  Submission Category 3. The submitter should submit test results and analysis from a new 
662  HF validation study for the subject device in an HF Report. The HF Report should include 
663 the use-related risk analysis, along with the information referenced in Table 3.
664
665 Example B.3.
666  Scenario: A submitter has an approved PMA for a stent with a balloon catheter delivery 
667  system. The submitter is requesting approval for a new stent under a new PMA that has a 
668  different stent design and coating. The new stent uses the same balloon catheter delivery 
669  system as the submitters own PMA-approved stent. The submitter is proposing to leverage 
670 the previous HF validation test results for the balloon catheter delivery system.
671 Decision Point A: Is it a modification to an existing device? 
672  Yes. The submitter is using their own existing PMA-approved balloon catheter delivery 
673 system with a new stent.
674 Decision Point B: Is there a change to any of the following:
675  User interface;
676  Intended device users;
677  Intended device uses;
678  Intended use environment(s);
679  Training; or
680  Labeling?
681  No. Even though the submitter has submitted a new PMA, in this case, the user-interface of 
682  the balloon catheter delivery system is the same as that used in the approved PMA. The only 
683  changes to the product are the stent design and coating, which are not user-interfacing and 
684  are based on the submitters approved PMA. The submitter evaluated the critical tasks, and 
685  none of them were impacted by the change in stent design and coating. The submitter can 
686 leverage the previous HF validation test results in their new PMA.
687
688  Analysis: The recommended HF information in this marketing submission is HF 
689  Submission Category 1. The submitter should include a statement justifying that the device 
690  modifications do not affect the human factors considerations of the modified device and the 
691 conclusion and high level summary of HF evaluation.
692
693
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New devices 
694 
695  Example C.1.  
696  Scenario: In an alternate scenario to Example B.3, the submitter is proposing to introduce 
697  the new stent as described above, along with a new balloon catheter delivery system that has 
698  a different design from the PMA-approved system.  
699 Decision Point A: Is it a modification to an existing device? 
700  No. The submitter is submitting a new PMA based on a new design of the catheter delivery 
701  system with a new stent. The submitter should proceed to Decision Point C. 
702 Decision Point C: Based on the use-related risk analysis, are there:
703  New devices only: Critical tasks? 
704   Modified devices only: New critical tasks introduced or are existing critical 
705 tasks impacted?
706 Yes. The submitter has determined based on the use-related risk analysis that there are 
707 critical tasks associated with the subject device.
708
709 Analysis: The recommended HF information in this marketing submission is HF 
710 Submission Category 3. The submitter should submit test results and analysis from a new 
711 HF validation study for the subject device in an HF Report. The HF Report should include 
712 the use-related risk analysis, along with the information referenced in Table 3.
713
714 Example C.2.
715 Scenario: The submitter submits a 510(k) to request clearance for a new portable fingertip 
716 oximeter intended for spot checking oxygen saturation of arterial hemoglobin ofadult 
717 patients in professional healthcare facilities and the home. This is the first portable oximeter 
718 device developed by the submitter. Therefore, the submitter uses a predicate device from a 
719 differentsubmitter. The subject device does not include any alarms or additional information 
720 interpreting the oxygen saturation, nor is it intended for life supporting or life-sustaining 
721 functions. The user of the device places the sensor on afinger and then reads the oxygen 
722 saturation values calculated by the device. The submitter comparestheir devicewith the 
723 predicate device to show the indications for use, use environment, and users are the same
724 between the two devices. 
725 Decision Point A: Is it a modification to an existing device? 
726  No. The submitter has manufactured a new device. For purposes of demonstrating substantial 
727 equivalence, the submitter has identified as a predicate a device from another device 
728 manufacturer. The submitter should proceed to Decision Point C.
729 Decision Point C: Based on the use-related risk analysis, are there:
730  New devices only: Critical tasks?
731  Modified devices only:New critical tasks introduced or are existing critical 
732 tasks impacted?
733 No. The submitter determined through their use-related risk analysis that the action of 
734 placing the sensor on a users finger and reading the oxygen saturation values could not 
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735  cause serious harm to the user/patient. The submitter further justifies this conclusion by 
736  stating the device is used as a spot-check and there are no alarms or additional information 
737 interpreting the results from the device.
738
739  Analysis: The recommended HF Submission Category in this marketing submission is HF 
740  Submission Category 2. The submitter should provide a rationale for why there are no 
741 critical tasks.
23