Design Considerations for Devices
`
`Intended for Home Use
`
`Guidance for Industry and
`
`
`Food and Drug Administration Staff
`
`
`
`
`Document issued on November 24, 2014.
`
`This document supersedes “Design Considerations for Devices Intended for
`Home Use” issued August 5, 2014.
`
`
`
`This document provides clarification about the use of standards applicable to
`supply mains (section VII-E-1) and electromagnetic compatibility (section
`
`VII-E-6).
`
`
`
`For questions about this document regarding CDRH-regulated devices, contact Mary Brady at
`301-796-6089 or by e-mail at mary.brady@fda.hhs.gov; or contact the Office of the Center
`Director at 301-796-5900.
`
`
`
`For questions about this document regarding CBER-regulated devices, contact the Office of
`Communication, Outreach, and Development (OCOD) at 1-800-835-4709 or 240-402-7800.
`
`U.S. Department of Health and Human Services
`Food and Drug Administration
`
`Center for Devices and Radiological Health
`
`Center for Biologics Evaluation and Research
`
`
`
`
`
`
`
`Page 1
`
`

`
`Contains Nonbinding Recommendations
`
`
`
`Preface
`
`
`
`
`Public Comment
`
`You may submit written comments and suggestions at any time for Agency consideration to the
`Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane,
`rm. 1061, (HFA-305), Rockville, MD, 20852. Submit electronic comments to
`http://www.regulations.gov. Identify all comments with the docket number FDA-2012-D-1161.
`Comments may not be acted upon by the Agency until the document is next revised or updated.
`
`Additional Copies
`CDRH
`
`
`
`
`
`Additional copies are available from the Internet. You may also send an e-mail request to
`CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document
`number 1750 to identify the guidance you are requesting.
`
`CBER
`
`
`Additional copies are available from the Center for Biologics Evaluation and Research (CBER)
`by written request, Office of Communication, Outreach and Development (OCOD), 10903 New
`Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD, 20993, or by calling 1-800-835-4709
`or240-402-7800, by email, ocod@fda.hhs.gov, or from the Internet at
`http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformatio
`n/Guidances/default.htm.
`
`
`
`Page 2
`
`

`
`     
`
`Contains Nonbinding Recommendations
`
`Table of Contents
`
`
`
`I.
`
`Introduction.......................................................................................................................................................... 1
`
`
` II. Background.......................................................................................................................................................... 2
`
`
`III. Scope .................................................................................................................................................................... 3
`
`
`IV. Definitions............................................................................................................................................................ 3
`
`
`V. Environmental Considerations .............................................................................................................................. 4
`
` 
` 
`A. Location............................................................................................................................................................ 4
`
` 
` 
`B. Contaminants .................................................................................................................................................... 4
`
` 
` 
`
`C. Water Supply .................................................................................................................................................... 5
`
` 
` 
`D. Temperature ...................................................................................................................................................... 5
`
` 
` 
`E. Dampness and Humidity .................................................................................................................................. 5
`
` 
` 
`F. Atmospheric Pressure Changes ........................................................................................................................ 5
`
` 
` 
`G. Air Flow ........................................................................................................................................................... 5
`
` 
`    
`H. Travel and International Use............................................................................................................................. 5
`
` 
` 
`Fluid Exposure ................................................................................................................................................. 6
`
`I.
` 
`J.
`Storage.............................................................................................................................................................. 6
`
`
`VI. User Considerations ............................................................................................................................................. 6
`
`    
` 
`A. Physical............................................................................................................................................................. 7
`
` 
` 
`Sensory/Perceptual ........................................................................................................................................... 7
`
`B.
` 
` 
`C. Cognitive .......................................................................................................................................................... 7
`
` 
`D. Emotional ......................................................................................................................................................... 7
`
`VII. Design Considerations .......................................................................................................................................... 7
`
` 
` 
`
`A. Lock-out Mechanisms ...................................................................................................................................... 9
`
` 
` 
`B. Maintenance ..................................................................................................................................................... 9
`
` 
`C. Calibration ........................................................................................................................................................ 9
`
`D. Mechanical ....................................................................................................................................................... 9
`
` 
` 
`E. Electrical Issues .............................................................................................................................................. 10
`
` 
` 
`1.
`Supply Mains ............................................................................................................................................. 10
`
` 
` 
`Internal Electrical Power Source ................................................................................................................ 10
`
`2.
` 
` 
`Permanently Installed Devices ................................................................................................................... 11
`
`3.
` 
` 
`4. Outlets and Adapters.................................................................................................................................. 11
`
` 
` 
`Power Outages ........................................................................................................................................... 11
`
`5.
` 
` 
`Electromagnetic Compatibility (EMC) ...................................................................................................... 11
`
`6.
` 
` 
` 7. Wireless Technology.................................................................................................................................. 12
`
`
` 
`8. Alarm Systems ........................................................................................................................................... 13
`
`VIII. Human Factors ................................................................................................................................................... 13
`
`    
`A. User Training and Certification ...................................................................................................................... 14
`
`
`IX. Labeling.............................................................................................................................................................. 15
`
` 
` 
`A. Handling the Device in an Emergency ........................................................................................................... 16
`
` 
` 
`B. Disposal.......................................................................................................................................................... 16
`
` 
`C. Hygienic Maintenance .................................................................................................................................... 16
`
`
`X. Postmarket Considerations ................................................................................................................................. 17
`
`     
` 
`A. Customer Service ........................................................................................................................................... 17
`
` 
`B. Medical Device Reporting .............................................................................................................................. 17
`
`
`XI. Conclusion........................................................................................................................................................... 18
`
`Appendix 1
`: List of References ................................................................................................................................... 19
`
`Appendix 2: Additional Resources.............................................................................................................................. 23
`
`
`  
`
`  
`
`  
`
`  
`
`  
`
`  
`
`    
`
`
`
`
`
`Page 3
`
`

`
`Contains Nonbinding Recommendations
`
`
`Design Considerations for Devices
`
`Intended for Home Use
`
`Guidance for Industry and
`
`Food and Drug Administration Staff
`
`
`
`
`
`This guidance represents the Food and Drug Administration's (FDA's) current thinking
`on this topic. It does not create or confer any rights for or on any person and does not
`operate to bind FDA or the public. You can use an alternative approach if the approach
`satisfies the requirements of the applicable statutes and regulations. If you want to discuss
`an alternative approach, contact the FDA staff responsible for implementing this
`guidance. If you cannot identify the appropriate FDA staff, call the appropriate number
`listed on the title page of this guidance.
`
`
`Introduction
`I.
`
`This guidance is intended to assist manufacturers in designing and developing home use
`devices that comply with applicable standards of safety and effectiveness and other
`regulatory requirements. Devices used in the home or other non-clinical environments are
`associated with unique risks created by the interactions among the user (often a layperson),
`the use environment, and the device. This guidance identifies several factors that
`manufacturers of home use devices should consider, especially during device design and
`development, and provides recommendations for minimizing these unique risks.
`
`Throughout this guidance the term “you” refers to manufacturers as defined in 21 CFR
`820.3(o). For convenience the definition is restated here: Manufacturer means any person
`who designs, manufactures, fabricates, assembles, or processes a finished device.
`Manufacturer includes, but is not limited to, those who perform the functions of contract
`sterilization, installation, relabeling, remanufacturing, repacking, or specification
`development, and initial distributors of foreign entities performing these functions.
`
`For additional information or questions about the FDA-recognized standards referenced in
`this guidance document, please contact CDRH’s Standards Program. 1
`
`
`
`
`
`
`
`
` 1 Web site addresses for all hyperlinked material in this guidance document can be found in Appendix 1: List
`of References.
`
`
`
`
`1
`
`Page 4
`
`

`
`Contains Nonbinding Recommendations
`
`
` FDA's guidance documents, including this guidance, do not establish legally enforceable
`responsibilities. Instead, guidance describes 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. Background
`
`For a variety of reasons, use of devices outside professional healthcare facilities is on the
`rise. First, the United States population is aging, and the elderly are more likely to live with
`chronic diseases that require daily medical care at home. Second, due to medical
`advancements, many individuals with chronic diseases are living longer but are dependent on
`home medical care. Finally, an increasing focus on reducing healthcare costs for patients of
`all ages has spurred the growth of the home health care market. Integral to the home health
`care market are home use devices. Although home use devices provide significant benefits to
`patients and families, including quality of life improvements and cost savings, they are also
`associated with unique risks. These risks result from interactions among the user, the use
`environment, and the device, and can greatly affect user and patient safety.
`
`Due to the increasing prevalence of home use devices, minimizing the risks they posed can
`greatly improve the public health. With this in mind, FDA developed the following
`considerations that can help manufacturers reduce or minimize common risks posed by home
`use devices. These risks are best addressed at the design stage. Failure to adequately consider
`potentially hazardous situations during the design of home use devices may result in
`inappropriate use, use error, or incompatibilities between the use environment, the user, and
`the device. This could cause the device to malfunction, possibly contributing to death or
`serious injury.
`
`When developing a new home use device, you should take the considerations in this
`guidance document into account and, to the extent possible, reduce or minimize risk to
`acceptable levels through device design (sometimes referred to as “designing risk out of the
`device”). For any premarket submission to FDA, you should ensure that the device is
`suitable for home use and provide in the submission data that demonstrate how you
`considered and addressed the relevant hazards and risks, such as the ones mentioned in this
`guidance document. This can help FDA determine whether applicable safety and
`effectiveness requirements have been met.
`
`Following the recommendations in this guidance can help you develop a device that is best
`suited to the home use environment, which should decrease the occurrence of adverse events
`by minimizing the risks to patient and user safety.
`
`
`
`
`
`2
`
`Page 5
`
`

`
`Contains Nonbinding Recommendations
`
`
`
`III. Scope
`
`This guidance provides recommendations for minimizing the risks associated with home use
`devices by considering the user, the use environment, the device or system, human factors,
`and labeling. This guidance applies to both prescription and over-the-counter (OTC) medical
`devices, including any class I, II, or III devices intended for home use.2 The
`recommendations in this document apply whenever you are designing or developing a home
`use device, as defined in Section IV of this document. This guidance also provides
`recommendations regarding postmarket considerations. These recommendations should also
`be considered when you are designing a device that is likely to be used in the home, even if
`the device is not intended solely for home use. Review this guidance for the factors that may
`be applicable to your device type.
`
`IV. Definitions
`The following definitions apply for purposes of this guidance document (Please note the
`definitions below are not intended for use outside this guidance document.):
`
`
`
`A home use device is a medical device labeled for use in any environment outside a
`professional healthcare facility. This includes but is not limited to outdoor environments,
`office environments, schools, vehicles, emergency shelters, and independent living
`retirement homes. If the device is intended to be used in professional healthcare facilities
`and also outside those facilities, it meets this definition.
`
`A user is a lay person such as a patient (care recipient), caregiver, or family member who
`directly operates or handles a device or provides assistance to the patient in using the device.
`
`Lay is a nonprofessional or professional person without relevant specialized training (e.g.,
`lay operator, lay responsible organization).
`
`
`
`A qualified healthcare professional is a licensed or non-licensed healthcare professional
`with sufficient skills and experience with the use of a device to aid or train someone to use
`and maintain the device.
`
`A professional healthcare facility is either –
`
`(1) any environment where personnel with medical training are continually available
`to oversee or administer the use of medical devices. This includes, but is not
`limited to, hospitals, long-term care facilities, nursing homes, emergency medical
`services, clinics, physicians’ offices, and outpatient treatment facilities; or
`
`(2) a clinical laboratory.
`
`
`
`
`2 Sponsors of home use in vitro diagnostic tests to diagnose HIV are advised to contact CBER to discuss issues
`related to those tests.
`
`
`
`3
`
`Page 6
`
`

`
`Contains Nonbinding Recommendations
`
`
`A clinical laboratory3 is a facility that (1) performs testing on materials derived from the
`human body for the purpose of providing information for the diagnosis, prevention, or
`treatment of any disease or impairment of, or assessment of the health of, human beings; and
`(2) has been certified to perform such testing under the Clinical Laboratory Improvement
`Amendments of 1988 (42 U.S.C. 263a) in accordance with 42 CFR part 493, or has met
`equivalent requirements as determined by the Center for Medicare and Medicaid Services in
`accordance with those provisions.
`
`
`V. Environmental Considerations
`
`When designing a home use device, you should account for the range of environments in
`which it might be used and the applicable environmental conditions noted below. These
`conditions should be addressed with all devices that will be used in a home or non-clinical
`setting. The labeling of the device should include warnings against using the device in
`environmental conditions that would raise safety or effectiveness concerns; however,
`managing risk by device design is preferable to managing risk through labeling. FDA
`recommends that, in your premarket submission for your device design, you include a
`summary of the efforts you took to account for the following considerations, if they pertain
`to the intended use environment for your device. If some of the items do not pertain to the
`type of equipment you are designing, then you will not have to consider them in your device
`design.
`
`A. Location
`
`Home use device design should permit the device to operate in its intended use location(s)
`(e.g., urban/suburban/rural, school/office/retail environments, and train/plane/car). Consider
`where the device will be used and how these locations would affect the user and the device’s
`ability to function and operate safely and effectively. For example, older buildings can have
`outlets that do not meet current electrical code or a limited number of outlets. See section
`VII-E-4 for further guidance. Home use device design should take into account the
`characteristics of the environment in which the device is intended to be used and stored.
`Your device design should permit the device to move in and out of the environment, as well
`as move from place to place within the environment (e.g., from room to room). Crowded use
`environments can interfere with device use and movement, present tripping hazards, or
`increase the likelihood that device parts will bump into or get tangled with objects in the
`environment. In addition, the device may not operate in a certain physical location if it relies
`on a wireless signal that may be unavailable.
`
`B. Contaminants
`
`Home use device design should permit the device to be operated in a non-sterile
`environment. The risk that the device could be affected by contaminants such as vermin,
`pets, tobacco smoke, and household chemicals should be mitigated as much as possible by
`
`3 See also 21 CFR 610.40(f).
`
`
`
`4
`
`Page 7
`
`

`
`Contains Nonbinding Recommendations
`
`
`designing the device to minimize the ingress of fluids, solids, and airborne particles that
`would affect device operation.
`
`C. Water Supply
`
`You should specify the type of water that is required to properly operate the home use
`device, e.g., well water or treated water. For additional information on keeping water safe,
`see the Centers for Disease Control and Prevention’s Web site on emergency preparedness
`and response.
`
`D. Temperature
`
`Home use devices should be designed for the anticipated temperature range in the intended
`use environment, especially those that are portable and might be exposed to fluctuations and
`extremes in temperature.
`
`E. Dampness and Humidity
`
`Home use devices should be designed for the variability in humidity levels that are expected
`to be present in the intended use environment, especially those that are portable and might be
`exposed to fluctuations and extremes in humidity.
`
`F. Atmospheric Pressure Changes
`
`Home use devices should be designed to operate properly within a range of atmospheric
`pressures such as lower pressures that occur in the mountains and during air travel.
`
`G. Air Flow
`
`Home use device design should ensure that air flow will be adequate for proper device
`operation.
`
`H. Travel and International Use
`
`Design of portable home use devices should anticipate that users will travel—internationally
`as well as domestically—with their medical devices and may use a variety of transportation
`modes as they travel. For electrical home use devices, you should provide information in the
`labeling on the adaptability of the device to the electrical supplies and voltage rates of other
`countries, and whether an adapter may be used to operate the device. Given that electrical
`power varies by country, electrical converters and battery back-up may be necessary to
`operate the device in a country outside the United States. Labeling should also include
`information on how users can get help if the device malfunctions while they are away from
`
`home.
`
`
`
`5
`
`Page 8
`
`

`
`Contains Nonbinding Recommendations
`
`
`
`In designing the device, you should also anticipate that users, including users of any body-
`worn medical devices, may be required to pass through security screening systems while
`traveling. These systems continue to evolve but currently include backscatter X-ray and
`millimeter wave technologies. You should consider whether these systems can interfere with
`the operation of the device. In addition, if users must undergo a security pat-down to avoid
`the automated screening system, you should consider how the procedure might affect body-
`worn medical devices, such as a continuous blood glucose sensor. In the instructions for use
`(IFU), consider referring the user to the Transportation Security Administration (TSA) Web
`site which includes information about procedures for travel with medical equipment.
`
`I.
`Fluid Exposure
`
`You should consider what the device can safely tolerate when it is subject to fluid spills or
`submersion, as well as the amount of fluid that the device can be exposed to without
`affecting its safe use.
`
`J.
`Storage
`
`You should provide information to the user about proper storage of the device and its
`components and accessories. For example, this could include, but is not limited to, keeping
`the device out of sunlight, keeping it at a proper temperature control, and keeping it dry
`between uses.
`
`
`VI. User Considerations
`
`The users of home use devices are different from the health care professionals who typically
`operate medical devices in a professional health care facility. Home users can have a large
`range of physical, sensory, and cognitive capabilities and disabilities, and emotional
`differences that should be considered in your home use device design. If the home use
`device is not designed for ease of use and understanding, you increase the likelihood of
`misuse and non-use of the device. Home use devices should be designed to prevent
`reasonably-foreseeable misuse. You should consider that children or adults might interact
`with the device in inappropriate ways.
`
`The following personal characteristics can affect device use and should be considered in the
`design of the device. Note that some home use devices are designed to diagnose or treat
`medical conditions that can cause functional impairments; therefore, it is important to design
`those devices to be usable by individuals with impairments. You should account for the
`following characteristics of your intended users in your device design. If a premarket
`submission is required, it should identify your intended users and include a summary of the
`actions you took to account for these characteristics.
`
`
`
`6
`
`Page 9
`
`

`
`Contains Nonbinding Recommendations
`
`
`A. Physical
`
`You should design for users with a range of physical sizes, mobility, dexterity, coordination,
`flexibility, strength, and stamina.
`
`B. Sensory/Perceptual
`
`You should design for users with a range of vision and hearing abilities and tactile
`sensitivities. In your home use device design, you should consider the visibility of the device
`interface under a variety of ambient lighting conditions, the visibility of any alarm signals
`and whether they will be differentiated from other sounds in the environment, the types of
`feedback mechanisms that will operate while the user is interacting with the device, and
`whether any perceptual issues might affect the user’s ability to use the device properly,
`which could include handling the device and the manner in which it touches the user.
`
`C. Cognitive
`
`You should design for users with a range of abilities to process information and literacy
`levels, and consider the potential that users might have some type of cognitive impairment
`that could affect how they interact with the home use device. Consider the amount of
`experience the users might have with a type of device and with similar devices, and how able
`and willing they might be to learn and adapt to using a new device.
`
`D. Emotional
`
`You should design for users who may be providing care for a loved one who is unable to use
`the device unassisted. Whether a person is providing care to others or performing self-care,
`he or she can be dealing with a new diagnosis or condition along with the need to operate a
`medical device, which can be overwhelming and cause anxiety for the user.
`
`VII. Design Considerations
`
`The Quality System regulation (QS regulation)4 describes requirements intended to help
`ensure that finished medical devices have a reasonable assurance of safety and effectiveness.
`For example, it requires that you establish and maintain procedures to control the design of
`the device to ensure that specified design requirements are met. This guidance document
`provides recommendations on technical issues to consider during the design and
`development of home use devices. This section outlines certain aspects of design control
`that are particularly important for home use devices.
`
`Under 21 CFR 820.30 -- Design Controls, a manufacturer must establish procedures to
`ensure that device design will translate into a device that performs properly according to its
`
`
`4 21 CFR Part 820.
`
`
`
`7
`
`Page 10
`
`

`
`Contains Nonbinding Recommendations
`
`
`intended use and user needs.5 Design control requirements of the QS regulation apply to
`design and development of the device as well as its packaging and labeling (e.g., Instructions
`for Use), and its cleaning, disinfection, and sterilization procedures. When establishing
`design controls for home use devices, you should take into account considerations related to
`device performance and user needs in the home environment, which are discussed in detail
`below. For more information about creating and implementing design controls, we
`recommend that you refer to FDA’s guidance Design Control Guidance for Medical Device
`Manufacturers (March 11, 1997).
`
`You should consider developing a risk management plan. This risk management plan should
`describe the process for identifying hazards, estimating and evaluating the known risks,
`controlling the risks, and monitoring the effectiveness of the controls. In your risk analysis,
`special attention should be paid to the possible causes of use-related errors and failures, as
`home use devices are exposed to more hazards than are present in professional health care
`facilities and present greater potential for harm caused by user error.
`
`Your risk management plan should also include elements to control risk that can enhance the
`ease of use for the intended user population based on human factors engineering methods
`(see Section VIII). You should first strive for the highest level of risk control possible by
`designing risk out of the system to the greatest extent possible. Methods to control risk and to
`enhance ease of use also include designing the device to reduce or minimize risks,
`developing protective measures in the device itself (e.g., an automatic shutoff), or providing
`information for safety. It is important to note that labeling alone generally does not offer
`sufficient risk control for the home use environment because warning labels, especially
`lengthy ones, can be ignored by or confusing to the user. Accounting for the considerations
`described in this document will help mitigate risk and guide device design so that it is
`appropriate for the intended user and use environment. We recommend that you review
`ANSI/AAMI/ISO14971:2007/(R) 2010, Medical devices – Application of risk management
`to medical devices.
`
`Software plays a critical role in the operation of some devices. For these devices, you should
`focus on developing device and software architecture and algorithms for performance, error
`detection, control, and recovery. When developing a home use device, you should broaden
`your existing concept development and preliminary testing processes to account for the needs
`of home users and requirements for straightforward device operation, obvious interface
`layouts, and appropriate alarm methods. If software upgrades are required, you should
`consider how this will be performed in the home environment with the lowest risk to the user
`and least burden on you.
`
`For software in general, we recommend that you review:
`
`
`
`
`
`
`IEC 62304 First edition 2006-05, Medical device software – Software life cycle
`processes and the identical standard ANSI/AAMI/IEC 62304:2006.
`
`
`
`
`5 See 21 CFR 820.30(g); see also 61 FR 52602 at 52616.
`
`
`
`8
`
`Page 11
`
`

`
`Contains Nonbinding Recommendations
`
`
`
` FDA’s guidance General Principles of Software Validation (January 11, 2002).
`
`
`
` FDA’s Guidance for the Content of Premarket Submissions for Software Contained
`
`in Medical Devices (May 11, 2005).
`
`A. Lock-out Mechanisms
`
`FDA recognizes that lockout mechanisms can be used for controlling access to certain device
`functions, such as preventing the patient from changing settings entered by the health care
`professional or caregiver. However, the safety of home use devices should not depend solely
`on such mechanisms. Before using a lock-out mechanism as the only mechanism to reduce
`or prevent patient harm, you shou