2022 Draft FDA Guidance - Content of Human Factors Information in Medical Device Marketing Submissions

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Preamble 🔗

This draft guidance document is being distributed for comment purposes only.

Document issued on December 9, 2022.

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.

Contains non-binding guidance.

I. Introduction¹ 🔗

FDA is committed to fostering the development of and patient access to innovative medical devices while balancing their benefits and risks. A unique aspect of medical devices is the critical role of device-user interface interactions for their safe use. Manufacturers routinely perform human factors assessments of the human-device interface during device development. This guidance provides a risk-based framework to guide manufacturers and FDA staff on the human factors information that should be included in a marketing submission to the Center for Devices and Radiological Health (CDRH) to facilitate the efficiency of the FDA review process.

The goal of the human factors assessment is to ensure that the device user interface has been designed such that use errors that occur during use of the device that could cause harm or degrade medical treatment are either eliminated or reduced to the extent possible. The main factors to consider in a risk-based approach to human factors assessment, as described in this draft guidance, include the identification of (i.e., presence of or modification to) critical tasks and the elimination or reduction of use-related hazards.

This guidance includes recommendations for the content of human factors and usability engineering information to be included in marketing submissions.² FDA’s decision on a medical device marketing submission is based on the applicable statutory and regulatory criteria (e.g., substantial equivalence for premarket notification (510(k)) submissions, reasonable assurance of safety and effectiveness for premarket approval applications (PMAs) or De Novo classification requests (De Novo requests)). Human factors, to the extent relevant, constitute just one component of FDA’s assessment. While FDA believes that it is optimal to minimize use-related risks, it may not be necessary, nor practical, to eliminate all use-related device risks.

The marketing submission should, where appropriate, demonstrate that the needs of the intended users were considered in the device design and that the device is safe and effective for the intended users, uses, and use environments. Thus, marketing submissions should include, where appropriate, information that explains the presence or absence of critical tasks, validation testing for risk mitigation strategies, and a description of residual risks. Including appropriate human factors information may improve the efficiency of FDA review by reducing the number of requests for additional information.

After considering stakeholder feedback on the draft guidance “List of Highest Priority Devices for Human Factors Review,”³ FDA has decided that it should issue another draft guidance regarding submission of human factors information for the purposes of premarket review, which will supersede the draft guidance “List of Highest Priority Devices for Human Factors Review.”

When finalized, this draft guidance is intended to be used to complement the FDA guidance “Applying Human Factors and Usability Engineering to Medical Devices”⁴ (hereafter referred to as the Human Factors Guidance). The purpose of the Human Factors Guidance is to recommend and guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. That guidance provides relevant human factors definitions and recommends useful preliminary analysis and evaluation tools and validation testing that will enable manufacturers to assess and reduce risks associated with medical device use. The purpose of the current guidance is to help manufacturers apply a risk-based approach when considering what human factors information to include in a marketing submission.

After reviewing public comment on this draft guidance and upon its finalization, FDA intends to concurrently revise the Human Factors Guidance to incorporate the definitions included in this guidance, superseding the definitions in Section 3 of the Human Factors Guidance. FDA also intends to concurrently revise the Human Factors Guidance by replacing Section 9 “Documentation” and Appendix A “Human Factors and Usability Engineering Report” of the Human Factors Guidance with cross-references to Section V of this guidance, and by making any other revisions to the Human Factors Guidance as appropriate.

For the current edition of the FDA-recognized consensus standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database.⁵ For more information regarding use of consensus standards in regulatory submissions, please refer to the FDA guidance titled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.”⁶

FDA recognizes and anticipates that the Agency and industry may need up to 60 days to perform activities to operationalize the policies within this guidance. If new information regarding the content of human factors information for marketing submissions is not included in a marketing submission received by FDA before or up to 60 days after the publication of the final guidance, CDRH staff does not generally intend to request such information during the review of the submission. CDRH does, however, intend to review any such information, if submitted.

In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.

II. Scope 🔗

This guidance is intended to help submitters and FDA staff determine what human factors evaluation information should be included in marketing submissions for medical devices, including 510(k)s, De Novo requests, PMAs, including PMA supplements, and humanitarian device exemption (HDE) applications.⁷

The guidance is not intended to inform manufacturers about how to perform a human factors evaluation. This guidance is also not intended to describe when a marketing submission should be submitted to legally market a new or modified device.

III. Definitions 🔗

The following definitions⁸ apply for the purposes of this guidance:

• Abnormal use: An intentional act or intentional omission of an act that reflects violative or reckless use or sabotage beyond reasonable means of risk mitigation or control through design of the user interface.
• 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.
• Formative evaluation: User interface evaluation conducted with the intent to explore user interface design strengths, weaknesses, and unanticipated use errors.⁹
• Harm: Injury or damage to the health of people, or damage to property or the environment.¹⁰
• Hazard: Potential source of harm.¹¹
• Hazardous situation: Circumstance in which people, property or the environment is/are exposed to one or more hazards.¹²
• Human factors engineering: Application of knowledge about human behavior, abilities, limitations, and other characteristics to the design of medical devices (including software), systems and tasks to achieve adequate usability.¹³
• Human factors validation testing: Testing conducted at the end of the device development process to assess user interactions with a device user interface to identify use errors that would or could result in serious harm to the patient or Human factors validation testing is also used to assess the effectiveness of risk management measures. Human factors validation testing represents one portion of design validation.
• Normal use: Operation, including routine inspection and adjustments by any user, and stand-by, according to the instructions for use or in accordance with generally accepted practice for those medical devices provided without instructions for use.¹⁴
• Residual risk: Risk remaining after risk control measures have been implemented.¹⁵
• Serious harm: Includes both serious injury and death.
• Serious injury: An injury or illness that is life-threatening, results in permanent impairment of a body function or permanent damage to a body structure, or necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body Permanent means irreversible impairment or damage to a body structure or function, excluding trivial impairment or damage.¹⁶
• Task: One or more user interactions with a medical device to achieve a desired result.¹⁷
• Use environment: Actual conditions and setting in which users interact with the medical device.¹⁸
• Use error: User action or lack of action that was different from that expected by the manufacturer and caused a result that (1) was different from the result expected by the user and (2) was not caused solely by device failure and (3) did or could result in harm.
• Use safety: How safe a device is when used or the extent to which risks of harm resulting from use error for medical devices have been either reduced to an acceptable level or eliminated completely.
• User: Person interacting with (i.e., operating or handling) the medical device.¹⁹
• User interface: Means by which the user and the medical device interact.²⁰
• Use-related risk: Combined probability, occurrence, and severity of harm for a given aspect of device use or for the overall use of a device.²¹
• Use-related risk analysis: Systematic use of available information to identify use-related hazards and to estimate the use-related risk.

IV. Risk­-based approach to human factors engineering information in marketing submissions 🔗

The purpose of including human factors engineering information in a marketing submission is to help the manufacturer meet the applicable legal standard by demonstrating that the user interface of the device is appropriate for the intended users, uses, and use environments. This section uses flowcharts, tables, and text to guide submitters through a risk-based approach to recommend what human factors engineering information a submitter should include in their marketing submission.

FDA refers to this risk-based approach as the Human Factors (HF) Submission Category. Submitters should use the flowchart in Figure 1 and use its companion text to answer the questions posed at each decision point to determine which HF Submission Category is appropriate to support their marketing submission. This flowchart is based on the device’s indications for use and the use-related risk analysis in the context of new devices and devices for which FDA has granted marketing authorization.

FDA based the HF Submission Categories on the presence of or modification to critical tasks, considering changes to technological characteristics or the indications for use, if relevant. Submitters should use the use-related risk analysis and the decision points described below to help determine the HF Submission Category for their marketing submission. Submitters should also reference Table 1 for FDA’s recommended human factors engineering information to provide in a marketing submission after they determine which HF Submission Category their submission falls under using

A. How to determine HF Submission Category 🔗

Decision Point A: Is it a modification to an existing device?

Submitters should answer “Yes” to this question when their submission is for a change to a device that has already received marketing authorization from FDA through a 510(k), PMA, HDE application, or De Novo request. Submitters should generally answer “No” if their device is a completely new device that has not received marketing authorization from FDA. Depending on specific facts and circumstances, submitters may be able to answer “Yes” to this question when they are proposing to apply human factors information from one of their own legally marketed devices to a subject device that has the same or a similar user interface.

Decision Point B: Is there a change to any of the following:

• User interface;
• Intended device users;
• Intended device uses;
• Intended use environment(s);
• Training; or
• Labeling?

This question applies to only modified devices and is intended to assess whether there have been any proposed changes that affect the human factors assessment. If the answer to this question is “No,” then the level of information would fall into HF Submission Category 1; however, if the answer is “Yes,” then the submitter should proceed to Decision Point C.

Decision Point C: Based on the use-related risk analysis, are there:

• New devices only: Critical tasks?²²
• Modified devices only: New critical tasks introduced or are existing critical tasks impacted?

The use-related risk analysis incorporating risk analysis approaches such as Failure Mode and Effects Analysis (FMEA), analysis of known use problems, and formative evaluation should be referenced to answer this question.²³ For modified devices, FDA recommends that submitters consider the use-related risk analysis on the final finished device and not just modifications to the device. This recommendation is intended to provide a holistic assessment of any critical tasks that could be impacted upstream or downstream from the altered device-user interface component.

Each identified critical task should be connected to the use-related risk analysis. When determining if a critical task has been affected by a change to the device-user interface, we recommend considering if those changes influence the cognitive and/or visual perception or the physical interaction between the user and the device. A reduction or increase in the steps to execute a critical task may be considered as affecting the critical task.

If there are no critical tasks for a new device, or no new critical tasks introduced, and no impacted critical tasks for a modified device based on the use-related risk analysis, the answer to this question is “No,” and the level of information would fall into HF Submission Category 2.

If the answer is “Yes,” then the level of information would fall into HF Submission Category 3.

B. What to include in a marketing submission based on HF Submission Category 🔗

Using the flowchart in

Figure 1 and its companion text to determine the HF Submission Category, manufacturers should include the following human factors information in marketing submissions:

HF Submission Category 1. Provide conclusion and high-level summary of HF evaluation: The submission should include a statement justifying that the device modifications do not affect the human factors considerations of the modified device and leverage, if applicable, previous human factors engineering evaluations to provide the conclusion and high level summary. See Table 1 for the suggested submission content for devices that fall into HF Submission Category 1.

HF Submission Category 2. Provide rationale in submission for why: there are no critical tasks (new devices only); or there are no new critical tasks introduced and/or no changes that impact critical tasks (modified devices only): The submitter should submit a rationale that clearly describes the basis of their decision that there are no critical tasks for a new device, or no new critical tasks introduced, and no impacted critical tasks for a modified device. This rationale should be based on the decision-making noted in Section IV.A that takes the submitter through each decision point. See Table 1 for the suggested submission content for devices that fall into HF Submission Category 2.

HF Submission Category 3. Provide a human factors engineering report that includes validation testing addressing: critical task(s) (new devices only; see Table 2); or new critical task(s) introduced or existing critical task(s) impacted by change (modified devices only; see Table 3): A comprehensive human factors engineering report that includes all elements of a human factors engineering report described in Section IV of this guidance should be submitted to FDA for marketing submissions in HF Submission Category 3. Please note that if critical tasks are impacted for a modified device, but existing risk control measures remain acceptable, you should provide your rationale in your submission as part of the human factors information.

Table 1. Recommended minimum human factors information that should be provided for a marketing submission based on HF Submission Category

Recommended information (Report section numbers from Section V below)	HF Submission Category
	1	2	3
Conclusion and high-level summary (Section 1)	✔	✔	✔
Descriptions of: Intended device users, uses, use environments, and training (Section 2) Device-user interface (Section 3) Summary of known use problems (Section 4)		✔	✔
Preliminary activities Summary of preliminary analyses and evaluations (Section 5)			✔
Use-related risk analysis Analysis of hazards and risks associated with use of the device (Section 6) Identification and description of critical tasks (Section 7)			✔
Details of validation testing of final design (Section 8)			✔

Table 2. Example tabular format for the use-related risk analysis

Use-related risk analysis Task #	User Task	Possible use error(s)	Potential hazards and clinical harm	Severity of harm	Critical Task (Y/N)	Risk Mitigation Measure(s)24	Validation method for effectiveness of risk mitigation measure25
Task #1
Task #2

Table 3. Example tabular format for the comparative use-related risk analysis

Existing Device						Modified Device			Submitter’s comparison comments
URRA Task #	User Task	Possible use error(s)	Potential hazards and clinical harm	Severity of harm	Critical task (Y/N)	Comparison of use task description to existing device	Labeling content and/or design change differences	Comparison of proposed risk mitigation measure to existing device
Task #1
Task #2

V. Recommended content of human factors information in marketing submissions 🔗

A manufacturer’s internal documentation of risk management, human factors engineering testing (when applicable), and design optimization processes can help provide evidence, where appropriate, that the needs of the intended users were considered in the design and that the device is safe and effective for the intended users, uses, and use environments. The Quality System Regulation (21 CFR part 820) requires that manufacturers of certain finished devices verify and validate device design, review and approve changes to device design, and document changes and approvals in the design history file (21 CFR 820.30). FDA recommends that human factors information be maintained by the manufacturer regardless of whether it is submitted to FDA. Manufacturers must keep records to the extent required under applicable law, including the Quality System Regulation (e.g., 21 CFR 820.30(j)), and these (and other) records must generally be made available to an FDA investigator upon request (see section 704(e) of the Federal Food, Drug, and Cosmetic Act).

This section describes the HF information that may be appropriate for submission to FDA in a marketing submission when one is required.²⁶ This human factors engineering information describes how the human factors engineering process was applied during the development of a medical device. Human factors engineering information should summarize the evaluations performed. Such information does not typically include all raw data from a human factors validation test. The information should discuss the safety-related human factors engineering considerations, processes, issues, resolutions, and conclusions. The information should describe the identification, evaluation, and final assessment of all use-related hazards from using the device.

Documents or analyses that are part of the human factors engineering process should be included in the human factors engineering information provided in a marketing submission. This includes portions of risk analyses focusing on user interactions with the device and specific risk analysis processes, results, and conclusions. Such information can also reference materials relevant to the human factors engineering process in other parts of the submission. A recommended structure for this human factors engineering information is further described below:

Section 1: Conclusion and high-level summary

Submitters should begin with a conclusion stating whether the user interface of the device has been found to be adequately designed for the intended users, uses, and use environments and whether new human factors testing was conducted to support this conclusion. FDA recommends that submitters begin with a high-level summary of the human factors engineering assessment (e.g., use-related risks), including the underlying rationale for conducting the assessment, and a summary of the human factors engineering processes conducted (e.g., human factors engineering analyses and evaluations, device-user interface modifications and validation testing) and analysis of the results.

When applicable, this section should discuss any remaining residual use-related risks after human factors validation testing. Submitters should describe why further risk mitigation is not practicable based on a benefit-risk analysis²⁷ for the device.

Section 2: Descriptions of intended device users, uses, use environments, and training

This section should include:

• A description of the intended user population. If there is more than one distinct user population, each population should be described. The description should include meaningful differences in capabilities or use responsibilities between user populations that could affect their interactions with the device. This includes lay and healthcare professional users who might use the same device to perform different tasks or different types of professionals who might perform different tasks on the device;
• A summary of the device’s intended use;
• A summary of the device’s operational context of use and critical aspects of device operation, including:
  • Whether users should or must be trained by a healthcare professional prior to device use;
  • How the device is used across clinical applications; and
  • Set up, maintenance, cleaning, and reprocessing information.
• A summary of the intended use environments (e.g., hospital, medevac vehicle, home use) and the characteristics of those environments (e.g., glare, vibration, ambient noise, high levels of activity) that could affect user interactions with the device; and
• A description of any training users would receive. A sample of the training materials such as a video, presentation slides, or a pamphlet may be appended.

Section 3: Description of device-user interface

When applicable, this section should include:

• A graphical representation (e.g., photographs, illustrations, line drawings) of the device and its user This should depict the overall device and all components of the user interface with which the user will interact (e.g., display and function screens, alarm speakers, controls, keypads, dedicated buttons, doors, components to be connected, retaining clips);
• A written description of the device user interface;
• A copy of the labeling that will be provided to the user with the device (e.g., instructions for use, user manual, quick-start guides, packaging);
• An overview of the operational sequence of the device and the user’s expected interactions with the user interface. This should include the sequence of user actions performed to use the device and resulting device responses, when appropriate; and
• For modified devices, consider providing information comparing the subject and existing devices (see Table 4 for an example format).

Table 4. Example tabular format for the comparison of the modified device user interface to the existing device

Modification description	Image of existing device-user interface component	Image of modified device-user interface component	Description of the modification made to the modified device
Modification #1
Modification #2

Section 4: Summary of known use problems

This section should describe all known use problems for previous models of the same device (as applicable) or with similar types of devices (e.g., predicate devices). FDA recommends that submitters state that there are no known use problems, if applicable. For a device that has been modified specifically in response to use problems in the field, this section should discuss those problems and the device modifications.

Section 5: Summary of preliminary analyses and evaluations

This section should identify the preliminary analysis and evaluation methods used (e.g., specific analysis techniques, formative evaluations), summarize the key results of those analyses and evaluations, describe modifications made to the user interface design in response, and discuss the key findings that informed the protocol development for the human factors validation test.

Section 6: Analysis of hazards and risks associated with use of the device

This section should include the use-related risk analysis document and/or comparative task analysis, as applicable. This is typically an excerpt from the comprehensive risk analysis that contains all use-related hazards and risks identified through the preliminary analyses and evaluations, including those associated with potential use errors. The use-related risk analysis document is intended to be a living document; updates should be made to identified risks and hazards throughout the device design process. FDA believes it can be useful to organize this information in a tabular format. An example tabular format is provided in Table 2. This example provides the recommended minimum information to evaluate the use-related risks associated with your device. For modified devices in HF Submission Category 3, the submitter should provide a comparative task analysis (see example tabular format in Table 3) comparing the modified device use-related risk analysis with the existing device use-related risk analysis.

If you determine that a device change resulting in a modification to any task, associated harm, and/or risk mitigation measure does not merit new HF validation test data to support the device’s use safety, please provide a rationale.

Section 7: Identification and description of critical tasks

This section should:

• Explain the process followed to identify the critical tasks based on the use-related risk analysis document. Since critical tasks are determined by the severity of the potential harm, FDA recommends that the submitter describe the levels of severity being used and use a reference when appropriate. For example, if the submitter is using a qualitative five-level severity rating from a voluntary consensus standard (e.g., ISO 14971²⁸), this section should include a table of severity levels with descriptions of each level and reference the applicable standard; and
• List and describe the critical tasks. For HF Submission Category 3, the submitter should provide a separate table highlighting the new critical tasks if relevant and rationale for why the task does not merit new HF validation test data to support the device’s use safety. The submitter should also describe each use scenario included in the human factors validation testing and list the critical and non-critical tasks that constitute each use scenario.

When modifying an existing device, FDA recommends that submitters compare the new device user interface to their own existing device in their marketing submission. FDA recommends completing this comparison in a tabular format. An example tabular format is provided in Table 4. In addition to the use-related risk analysis document for the entire device, submitters should include a subset of the use-related risk analysis that isolates tasks and risks associated with the proposed modifications made to the device. FDA recommends including photographic images of the device-user interface components that were modified, including modifications to labeling such as warning statements in an instructional manual. Submitters should list any critical tasks affected by the modification(s). Submitters should also discuss whether the risk associated with the modification is acceptable and assess whether the proposed changes warranted human factors validation testing. As stated in the Human Factors Guidance,²⁹ the validation test may be limited to assessment of those aspects of users’ interactions and tasks that were affected by the design modifications.

Section 8: Details of HF validation testing of final design

ANSI/AAMI/ISO 14971: Medical devices—Application of risk management to medical devices.

This section should summarize all HF validation activities conducted. In addition to test results, this section should have a comprehensive analysis of all use errors and problems that occurred that could have resulted in harm in real-world use, a description of all design modifications made to the user interface in response to the test results, and a benefit-risk discussion. A full test protocol and a sample of all scripts and forms used in the testing should be appended. Submitters should provide a residual risk analysis and the rationale for why existing mitigation controls are acceptable. While elimination of all residual risks may not be practicable, submitters should have evidence of a systematic analysis of use errors and mitigations of use-related risks.³⁰ Submitters should reevaluate risk control and mitigation measures to identify other means to reduce risk when it is determined that the residual risks are unacceptable.

VI. Examples 🔗

The following are hypothetical examples of scenarios intended to illustrate FDA’s risk-based approach to determine the HF Submission Category using the flowchart in Figure 1³¹ and its companion text. Based on the HF Submission Category, FDA’s recommended HF information to support the marketing submission is outlined for each scenario. These examples do not account for every submission type nor the human factors information that may be appropriate for every situation. Additionally, the examples describing modifications to an existing device are based on an assumption that a manufacturer has already determined that it needs to submit a new marketing submission. Therefore, these examples are not intended to interpret when a new marketing submission is required. In addition, these examples are not intended to comprehensively represent what should be included in a marketing submission for a new or modification to an existing device.

A. Modification to an existing 510(k)-­cleared device 🔗

Example A.1.

Scenario: A submitter currently has marketing authorization for a gastrointestinal lesion software detection system³² in a cleared 510(k). The device is a computer-assisted detection device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. The submitter has proposed to modify the computer-assisted detection algorithm such that a new 510(k) was submitted. The algorithm modifications improve the system’s ability to assist in detection of lesions and does not change any aspects of the device-user interface.

Decision Point A: Is it a modification to an existing device?

Yes. The submitter is modifying their own existing 510(k)-cleared device and using that device as the predicate device.

Decision Point B: Is there a change to any of the following:

• User interface;
• Intended device users;
• Intended device uses;
• Intended use environment(s);
• Training; or
• Labeling?

No. The changes to the algorithm do not impact any aspect of the device-user interface. The intended users, uses, and use environments remain the same and in this instance, changes to the algorithm do not include modifications to the labeling or training programs.

Analysis: The recommended HF information in this marketing submission is defined by HF Submission Category 1. The submitter should include a statement justifying that the device modifications do not affect the human factors considerations of the modified device and the conclusion and high level summary of HF evaluation.

Example A.2.

Scenario: A submitter currently has marketing authorization for a gas machine for anesthesia in a cleared stand-alone device 510(k) submission. The gas machine for anesthesia is intended for use in the hospital environment and includes a touch screen graphical user interface (GUI) and control knobs to regulate gas flow. The submitter requests 510(k)-clearance for a modification to the internal gas valving system and included in their 510(k) labeling changes to reflect the modification. There are no changes to the apparent flow settings from this internal change. Any modifications regarding calculated flow rates are made in software settings.

Decision Point A: Is it a modification to an existing device?

Yes. The submitter is modifying their own existing 510(k)-cleared device and using that device as the predicate device.

Decision Point B: Is there a change to any of the following:

• User interface;
• Intended device users;
• Intended device uses;
• Intended use environment(s);
• Training; or
• Labeling?

Yes. The labeling (instructions manual) was changed to describe the modification to the internal gas valving system. This change does not impact any external user interface component on the device itself. There are no changes to the intended device users, uses, intended use environment, or training because there are no such changes to the indications for use.

Decision Point C: Based on the use-related risk analysis, are there:

• New devices only: Critical tasks?
• Modified devices only: New critical tasks introduced or are existing critical tasks impacted?

No. Even though the labeling (instructions manual) has changed, this change does not impact how the intended user is expected to interact with the device because the user is not intended to directly interact with the gas valving system, since it is an internal component. There are no changes that influence the cognitive and/or visual perception or the physical interaction between the user and the device. Therefore, there are no new critical tasks introduced, nor are existing critical tasks impacted.

Analysis: The recommended HF information in this marketing submission is defined by HF Submission Category 2. The submitter should provide a rationale that clearly describes the basis of their decision that there are no new critical tasks introduced, and no impacted critical tasks for their modified device.

Example A.3.

Scenario: In addition to the change described in Example A.2, the submitter also requests 510(k) clearance to change the font size from 12 to 14 point on the text displayed on the graphical user interface (GUI) of the gas machine for anesthesia, along with a proportional increase in the screen’s physical size. The submitter is also making associated software changes to address the proposed change in the font size. The GUI menu does not change in terms of selection layout and contains the same icons representing different intended actions.

Decision Point A: Is it a modification to an existing device?

Yes. The submitter is modifying their own existing 510(k)-cleared device and using that device as the predicate device.

Decision Point B: Is there a change to any of the following:

• User interface;
• Intended device users;
• Intended device uses;
• Intended use environment(s);
• Training; or
• Labeling?

Yes. There are changes to the user interface from the software changes because the user is intended to directly interact visually with the words on the touch screen GUI, which the submitter states is the only part of the device being modified. There are no changes to the intended device users, uses, intended use environment, training, or labeling.

Decision Point C: Based on the use-related risk analysis, are there:

• New devices only: Critical tasks?
• Modified devices only: New critical tasks introduced or are existing critical tasks impacted?

No. Even though the user interface (GUI) was changed to include larger text font and a larger screen display, this change does not impact how the intended user is expected to interact with the device because the same textual information is being presented in the same layout and format. The text size change was assessed to introduce no negative influence on the cognitive and/or visual perception or the physical interaction between the user and the device. In this case, the submitter can choose to provide formative data and/or literature supporting this conclusion. Therefore, there are no new critical tasks introduced, nor are existing critical tasks impacted.

Analysis: The recommended HF information in this marketing submission is HF Submission Category 2. The submitter should provide a rationale (e.g., analysis of a literature review for acceptable font size) that clearly describes the basis of their decision that there are no new critical tasks introduced, and no impacted critical tasks for their modified device.

Example A.4.

Scenario: The submitter requests to change the GUI of the gas machine for anesthesia described in Example A.2. The proposed changes consist of changing textual menu selection items to icons (i.e., graphics). In addition, the submitter requests a change from the physical knob interface with discrete values for gas flow control to a digital slider with continuous values within a pre-specified range that became an added feature to the touch screen GUI. Based on these changes, the submitter updated the labeling, including the user manual and instructions for use, and training.

Decision Point A: Is it a modification to an existing device?

Yes. The submitter is modifying their own existing 510(k)-cleared device and using that device as the predicate device.

Decision Point B: Is there a change to any of the following:

• User interface;
• Intended device users;
• Intended device uses;
• Intended use environment(s);
• Training; or
• Labeling?

Yes. There are changes to the user interface because the user directly interacts visually with the icons and controls on the touch screen GUI. There is also a change in the way the user controls the gas flow. There are no changes to the intended device users, uses, or intended use environment. Both the submitter’s training and labeling have changed based on the changes to the touch screen GUI.

Decision Point C: Based on the use-related risk analysis, are there:

• New devices only: Critical tasks?
• Modified devices only: New critical tasks introduced or are existing critical tasks impacted?

Yes. There are several critical tasks associated with the main touch screen GUI of the gas machine for anesthesia, such as setting the ventilation mode, setting tidal volume and inspiratory pressure, and setting alarms. Changing the GUI to include only icons instead of text for menu selections may impact the ability of the user to comprehend the correct selection. There are also critical tasks associated with setting and controlling the gas flow to the patient. The interface for gas flow control changed from a physical knob to a digital slider on the touch screen interface, which impacts the physical interaction the user might have with the gas flow control. Although the same information is being conveyed, it is displayed in a different layout and format compared to the predicate.

Analysis: This requested change would be considered HF Submission Category 3. The submitter should submit test results and analysis from a new HF validation study for the subject device in an HF Report. The HF Report should include the use-related risk analysis, along with the information referenced in Table 3.

B. Modification to an existing PMA­-approved device 🔗

Example B.1.

Scenario: An implantable infusion pump has a physician programmer and both have been approved as a standalone device through the PMA process. The approved physician programmer is a personal digital assistant (PDA) device, with a monochrome screen and physical buttons to control scrolling and menu selection. The submitter requests approval in a PMA Supplement for a modification to the reservoir volume of the infusion pump. This proposed change does not result in any change to medication concentration or dosing calculation. The software is being updated to allow for the proposed volume change. The proposed modifications, including the software changes, have no direct effect on the device with which a physician or patient directly interact.

Decision Point A: Is it a modification to an existing device?

Yes. The submitter is modifying their own existing PMA-approved device.

Decision Point B: Is there a change to any of the following:

• User interface;
• Intended device users;
• Intended device uses;
• Intended use environment(s);
• Training; or
• Labeling?

Yes. The labeling (instructions manual) was updated to specify the change in the reservoir volume.

Decision Point C: Based on the use-related risk analysis, are there:

• New devices only: Critical tasks?
• Modified devices only: New critical tasks introduced or are existing critical tasks impacted?

No. There are critical tasks that could in some circumstances be impacted by a change in the reservoir volume, including medication concentration and the dosing that are related to drug delivery to the patient. In this case, the medication concentration and dosing remained the same, even with the change in reservoir volume. Therefore, no critical tasks were impacted by the change in reservoir volume.

Analysis: The recommended HF information in this marketing submission is HF Submission Category 2. The submitter should provide a rationale (e.g., discussion of how the change in total reservoir volume does not affect critical tasks such as setting concentration or calculating dosage) that clearly describes the basis of their decision that there are no new critical tasks introduced, and no impacted critical tasks for their modified device.

Example B.2.

Scenario: Like 0, an implantable infusion pump has a physician programmer and both have been approved through the PMA process. The approved physician programmer is a PDA device, with a monochrome screen and physical buttons to control scrolling and menu selection. The submitter requests approval in a PMA Supplement for a modification to the physician programmer from the approved monochrome PDA to a mini-tablet computer with a touch screen user interface. The display on the tablet computer will feature a full color display and new icons for menu functions.

Decision Point A: Is it a modification to an existing device?

Yes. The submitter is modifying their own existing PMA-approved device.

Decision Point B: Is there a change to any of the following:

• User interface;
• Intended device users;
• Intended device uses;
• Intended use environment(s);
• Training; or
• Labeling?

Yes. The introduction of new icons, color selection and display, and new menu orientation, has changed the user interface. Due to these changes, the submitter is also proposing to change the relevant training and labeling (instructions manual).

Decision Point C: Based on the use-related risk analysis, are there:

• New devices only: Critical tasks?
• Modified devices only: New critical tasks introduced or are existing critical tasks impacted?

Yes. In this case, the submitter evaluated the existing critical tasks, and some were impacted. Dose calculation function is impacted by additional (new) icon access on new home screen for unit selection and confirmation. Additional steps and workflow with new icon could cause user negative transfer of experience and lead to delay of therapy.

Analysis: The recommended HF information in this marketing submission is HF Submission Category 3. The submitter should submit test results and analysis from a new HF validation study for the subject device in an HF Report. The HF Report should include the use-related risk analysis, along with the information referenced in Table 3.

Example B.3.

Scenario: A submitter has an approved PMA for a stent with a balloon catheter delivery system. The submitter is requesting approval for a new stent under a new PMA that has a different stent design and coating. The new stent uses the same balloon catheter delivery system as the submitter’s own PMA-approved stent. The submitter is proposing to leverage the previous HF validation test results for the balloon catheter delivery system.

Decision Point A: Is it a modification to an existing device?

Yes. The submitter is using their own existing PMA-approved balloon catheter delivery system with a new stent.

Decision Point B: Is there a change to any of the following:

• User interface;
• Intended device users;
• Intended device uses;
• Intended use environment(s);
• Training; or
• Labeling?

No. Even though the submitter has submitted a new PMA, in this case, the user-interface of the balloon catheter delivery system is the same as that used in the approved PMA. The only changes to the product are the stent design and coating, which are not user-interfacing and are based on the submitter’s approved PMA. The submitter evaluated the critical tasks, and none of them were impacted by the change in stent design and coating. The submitter can leverage the previous HF validation test results in their new PMA.

Analysis: The recommended HF information in this marketing submission is HF Submission Category 1. The submitter should include a statement justifying that the device modifications do not affect the human factors considerations of the modified device and the conclusion and high level summary of HF evaluation.

C. New devices 🔗

Example C.1.

Scenario: In an alternate scenario to Example B.3, the submitter is proposing to introduce the new stent as described above, along with a new balloon catheter delivery system that has a different design from the PMA-approved system.

Decision Point A: Is it a modification to an existing device?

No. The submitter is submitting a new PMA based on a new design of the catheter delivery system with a new stent. The submitter should proceed to Decision Point C.

Decision Point C: Based on the use-related risk analysis, are there:

• New devices only: Critical tasks?
• Modified devices only: New critical tasks introduced or are existing critical tasks impacted?

Yes. The submitter has determined based on the use-related risk analysis that there are critical tasks associated with the subject device.

Analysis: The recommended HF information in this marketing submission is HF Submission Category 3. The submitter should submit test results and analysis from a new HF validation study for the subject device in an HF Report. The HF Report should include the use-related risk analysis, along with the information referenced in Table 3.

Example C.2.

Scenario: The submitter submits a 510(k) to request clearance for a new portable fingertip oximeter intended for spot checking oxygen saturation of arterial hemoglobin of adult patients in professional healthcare facilities and the home. This is the first portable oximeter device developed by the submitter. Therefore, the submitter uses a predicate device from a different submitter. The subject device does not include any alarms or additional information interpreting the oxygen saturation, nor is it intended for life supporting or life-sustaining functions. The user of the device places the sensor on a finger and then reads the oxygen saturation values calculated by the device. The submitter compares their device with the predicate device to show the indications for use, use environment, and users are the same between the two devices.

Decision Point A: Is it a modification to an existing device?

No. The submitter has manufactured a new device. For purposes of demonstrating substantial equivalence, the submitter has identified as a predicate a device from another device manufacturer. The submitter should proceed to Decision Point C.

Decision Point C: Based on the use-related risk analysis, are there:

• New devices only: Critical tasks?
• Modified devices only: New critical tasks introduced or are existing critical tasks impacted?

No. The submitter determined through their use-related risk analysis that the action of placing the sensor on a user’s finger and reading the oxygen saturation values could not

cause serious harm to the user/patient. The submitter further justifies this conclusion by stating the device is used as a spot-check and there are no alarms or additional information interpreting the results from the device.

Analysis: The recommended HF Submission Category in this marketing submission is HF Submission Category 2. The submitter should provide a rationale for why there are no critical tasks.

Footnotes 🔗