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). 
This document was updated August 8, 2016 to correct the transition date for 
ANSI/AAMI/IEC 60601-1-2. 
For questions about this document regarding CDRH-regulated devices, contact Tosia Hazlett at 
301-796-6119 or by e-mail at Tosia.Hazlett@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  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.  
  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
I.  Fluid Exposure.................................................................................................................................................6
J.  Storage ..............................................................................................................................................................6
VI.  User Considerations ..........................................................................................................................................6
A.   Physical........................................................................................................................................................7
B.  Sensory/Perceptual...........................................................................................................................................7
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
2.   Internal Electrical Power Source ................................................................................................................10
3.   Permanently Installed Devices ...................................................................................................................11
4.   Outlets and Adapters ..................................................................................................................................11
5.   Power Outages ...........................................................................................................................................11
6.   Electromagnetic Compatibility (EMC) ......................................................................................................11
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
   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.  
I.  Introduction 
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 CDRHs 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  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  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  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 devices 
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  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 Preventions 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 travelinternationally 
as well as domesticallywith 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  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  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 users 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  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 FDAs 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  Contains Nonbinding Recommendations 
 
  FDAs guidance General Principles of Software Validation (January 11, 2002).  
  FDAs 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 should first rule out other design solutions. However, if a lock-
out mechanism is the only mechanism available to reduce or prevent patient harm, it should 
be used. 
B.  Maintenance 
Home use devices might require routine maintenance for continued optimal performance.  
We recommend that you minimize the requirements for maintenance to the extent possible.  
When required, maintenance procedures should be easy to follow, clearly explained, and 
have a logical flow. 
C.   Calibration 
Home use devices should be designed without the need for calibration, but if that is not 
possible, the device should be designed to require minimal calibration by the user. 
Calibration instructions should be step-by-step and preferably provide the user with any 
feedback necessary to complete the calibration process. This could also include an indication 
on the device that states that it is calibrated, when it was last calibrated, and when the next 
calibration is needed.  
When the performance of the device depends on the use of calibrators, the traceability of the 
values assigned to these calibrators should be assured through a quality management system.  
If the device calibration needs to be done by a trained professional, you should indicate 
whether the device can remain in the home or has to be calibrated in another location. You 
should refer to available consensus standards and FDA guidance documents particular to the 
type of device that you are designing to review specific calibration requirements.   
D.   Mechanical  
Because some home use devices are portable and will be moved around frequently, it is 
critical to test them to see how they function after impact with the ground or other objects. 
Devices should have a minimal number of parts that could be detached or fall off and present 
an inhalation, swallowing, or tripping hazard. 
  9  Contains Nonbinding Recommendations 
 
The standard ANSI/AAMI HA60601-1-11:2011 Medical electrical equipment - Part 1-11: 
General requirements for basic safety and essential performance  Collateral standard: 
Requirements for medical electrical equipment and medical electrical systems used in the 
home healthcare environment includes information on mechanical strength for both transit 
operable and non-transit operable electrical medical devices. The medical device and its 
parts, including mounting and other accessories, should have adequate mechanical strength 
so that they can withstand stress caused by normal use that includes pushing, dropping, rough 
handling, freefall, vibration, and impact with the ground or another object.  If the device will 
be used while the user is in transit, the device should have adequate mechanical strength and 
durability to withstand normal transport conditions on trains, road vehicles, cycles, ships, and 
aircraft. FDA also recommends that you review ASTM D4169-09, Standard practice for 
performance testing of shipping containers and systems, for mechanical strength in the 
design of medical devices. For portable medical devices that are intended to be used only 
with a carrying case, the case should be tested along with the device. 
E.   Electrical Issues 
Design of home use devices that use electricity should take into account that some use 
environments might have unreliable sources of electricity and poor electrical grounding. The 
General Standard ANSI/AAMI ES60601-1:2012 (edition 3.1), Medical electrical equipment 
 Part I: General requirements for basic safety and essential performance includes 
information regarding the following electrical issues related to medical devices: 
1.   Supply Mains 
If your device operates from the supply main, you should consider using the applicable 
specifications of ANSI/AAMI ES60601-1:2012 (Edition 3.1) and ANSI/AAMI HA60601--1-
-11:2011. The latter specifies voltage ranges over which life-supporting medical devices and 
medical devices that are not life-supporting should provide their basic safety and essential 
performance. The following standards have specifications regarding short-term voltage 
interruptions and specifications regarding long-term interruptions of the supply mains: 
ANSI/AAMI/IEC 60601-1-2 Fourth edition 2014-02, Medical electrical equipment, Part 
1-2: General requirements for basic safety and essential performance  Collateral 
standard: Electromagnetic disturbances  Requirements and tests.6 
2.   Internal Electrical Power Source 
                                                           
6 FDAs recognition of the 2014 version of the IEC 60601-1-2 is available at 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/detail.cfm?standard__identification_no=34000.  
Please note that the 2014 version of the IEC 60601-1-2 standard includes a transition period through December 
31, 2018 as noted in FDAs recognition.  You may consider using IEC 60601-1-2:2007 during this transition 
period.  FDAs recognition of the 2007 version of the IEC 60601-1-2 is available at 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/detail.cfm?standard__identification_no=33996.
  10  Contains Nonbinding Recommendations 
 
If device operation depends on an internal electrical power source (e.g., batteries), the 
instructions for use (IFU) should describe the typical operation time or number of procedures 
and the typical service life of the power source.  If the device uses a rechargeable power 
source, the IFU should explain whether the device can be used while it is charging. If the 
internal power source is replaceable, the IFU should explain the replacement process 
procedure. If a device operates on battery power, you should inform the user how long he or 
she can expect the device to work on a fully charged battery. To the extent possible, the 
device should notify the user in advance that the battery will need to be recharged or replaced 
soon.  The design should consider that the user might not routinely recharge the device or 
might select inexpensive batteries that could otherwise result in suboptimal performance.  
3.   Permanently Installed Devices 
If a device is to be permanently installed in a home, the labeling should include clear 
information and specifications about proper protective grounding and recommend that the 
installation should be performed by a qualified professional.  
4.   Outlets and Adapters 
You should inform the user if the device should not share an outlet with another electrical 
device or be connected to an outlet controlled by a wall switch. You should also consider 
whether surge protectors, extension cords, or ground fault interrupters are appropriate for use 
with your device and inform the user accordingly. As some plugs are not compatible with 
some outlets in the home, your IFU should inform the user about the type of adapter, if any, 
that can be used and how to use it safely with the device.7  
5.   Power Outages 
If a device requires AC power to operate, you should consider providing or identifying back-
up power options, such as a battery or generator.  You should also provide instructions in the 
device labeling for emergency contact information in the event of a power outage (e.g., 
manufacturer, power supply company, or clinical care provider, as appropriate).  If the device 
cannot operate without a backup power supply, this should be noted either on the device or in 
the warnings section of the IFU. The manufacturer could also identify alternative means of 
providing the same or similar treatment that does not require using an electrical device. The 
IFU should disclose the continued device use time or number of procedures available 
following a loss or failure of the electrical power supply. If you provide a backup power 
source with your device, your IFU should specify how long the user should expect the device 
to work on backup power. 
6.   Electromagnetic Compatibility (EMC) 
                                                           
7 NOTE: ANSI/AAMI HA 60601-1-11:2011 specifies that equipment intended for  home healthcare use a two-
pronged plug or be battery powered. 
  11  Contains Nonbinding Recommendations 
 
Electromagnetic compatibility (EMC) is the ability of a device to operate properly in the 
presence of electromagnetic disturbances that are expected to occur in the environments of 
intended use without introducing excessive electromagnetic disturbances into that 
environment. FDA recommends that you consider using the FDA-recognized 
ANSI/AAMI/IEC 60601-1-2 Edition 4:2014-02 standard, which describes EMC testing and 
includes tests for immunity of the device to outside electromagnetic disturbances in the use 
environment and also for emissions from the device into that environment. If you use 
ANSI/AAMI/IEC 60601-1-2 Edition 3:2007 during the transition period to Edition 4 that 
ends December 31, 2018, you should be aware that electromagnetic disturbance in the home 
healthcare environment can exceed the default test levels for the hospital environment that 
are specified in Edition 3. You should design your device intended for home use to be 
immune to disturbance levels that can be expected in the home healthcare environment.8  
You should provide summary information in your premarket submissions to FDA describing 
the testing that was performed and how it was conducted, the device functions and modes 
that were tested, the pass/fail criteria used, reference standards and any deviations or 
allowances that were taken, any device modification needed to pass the testing, and 
appropriate labeling. Device manufacturers should consider appropriate levels of testing in 
accordance with the risks presented by the environments of intended use in addition to the 
general immunity testing specified in the standards.  
You should also note possible sources of disturbance for electrically powered medical 
devices in the use location(s) that could be near or in contact with other objects that would 
interfere with their performance, such as large electric motors or amateur radio transmitters, 
radio and television transmitters, radar, anti-theft systems (including demagnetizers), stereo 
speakers, cell phone, and radio frequency identification (RFID).  
7.   Wireless Technology 
If a device incorporates radio frequency (RF) wireless technologies, the device description in 
the premarket submission should contain a complete description of the exact wireless 
technology used, frequency and frequency band, output power, functions, including any 
alarm conditions communicated wirelessly, performance, and risk management. Compliance 
of RF wireless technologies with applicable technology standards and Federal 
Communications Commission (FCC) rules does not necessarily alleviate home use device 
safety and effectiveness concerns. Any submission for a device that includes RF wireless 
technology should address the areas of concern listed in FDAs guidance Radio Frequency 
Wireless Technology in Medical Devices (August 13, 2013). Particular points to address 
                                                           
8 Although not a requirement, the Agency generally finds testing to the following immunity tests levels 
acceptable for the home environment based on FDAs experience with home use devices: Electrostatic 
Discharge (ESD):  8 kV contact discharge,  15 kV air discharge; Power frequency magnetic fields: 30 A/m at 
50 Hz or 60 Hz; Conducted RF: 3 V r.m.s outside industrial, scientific, and medical (ISM) and amateur radio 
bands between 0.15 MHz and 80 MHz, 6 V r.m.s. in ISM and amateur radio bands between 0.15 MHz and 80 
MHz; Radiated RF: 10 V/m, 80 MHz to 2.6 GHz.  You may provide justification for testing to alternative 
levels. 
  12  Contains Nonbinding Recommendations 
 
include quality of service needed, data integrity, coexistence, security, and EMC of the 
wireless signals based on the use of the data intended by the manufacturer.  
Due to the increased use of RF wireless technology that operates in shared frequency bands, 
if applicable, you should carefully address RF wireless coexistence through testing the device 
with other common applications of RF wireless technology that can be expected to be present 
in the environment of use. If it can be expected that two or more similar devices will be 
operating wirelessly in close proximity (e.g., mobile or body worn devices located in a 
waiting room or the same room of a home), the ability to operate properly under these 
conditions should also be tested. 
8.   Alarm Systems 
Alarm systems are of particular concern for home use devices because noise and other 
distractions inside and outside the home can interfere with the users ability to be made 
aware of an alarm signal. For example, users can have hearing impairments, including the 
inability to hear specific frequencies. Device alarm systems with high or medium-priority 
alarm signals should be designed to be perceived in environments typically found in the 
home.  If the alarm system incorporates wired or wireless connections to other locations, the 
entire device system should be designed and tested to mitigate risks from loss or degradation 
of these connections.   
Alarm signals may not apply to all devices.  If the need for an alarm applies to your device, 
FDA recommends that you provide alarm signals in at least two of the three following 
modes: visual, auditory, tactile.  This alarm signal could be localized to the area where the 
device is being operated or in another location, which is known as a distributed alarm system. 
For example, the alarm could sound in another room or in a remote location where it is being 
monitored.  FDA recommends that you consider using the following standard: 
  IEC 60601-1-8 Edition 2.1 2012-11, Medical electrical equipment; Part 1-8; General 
requirements for basic safety and essential performance; Collateral Standard: 
General requirements, tests and guidance for alarm systems in medical electrical 
equipment and medical electrical systems. 
VIII. Human Factors 
To understand the hazards associated with the use of a medical device in the home, it is 
necessary to have an accurate and complete understanding of how a device will be used. 
Understanding and optimizing how people use and interact with technology is the subject of 
human factors engineering.  
Human factors engineering offers well-established methods to identify design issues that 
could affect medical device safety and efficacy. One particularly effective human factors 
method is to conduct usability testing. In a typical usability test session, representative 
device users perform selected tasks under conditions of simulated (not actual) use in an 
appropriately realistic environment. Depending on the nature of the device and the goals of 
  13  Contains Nonbinding Recommendations 
 
the test, the test environment could range from a conference room to a sophisticated, high-
fidelity simulation of the expected use environment or an actual home.  Testing early in the 
design process and then several more times as the design evolves is an effective way to 
prevent user interaction problems from persisting into the later stages of the design process, 
at which point effective solutions to problems may be more limited and more expensive to 
implement.9 Following the formative stage of design development, FDA recommends that 
you conduct a human factors validation study.10  
We recommend that you consult FDAs guidance on this topic, Applying Human Factors and 
Usability Engineering to Medical Devices (February 3, 2016), that represents FDAs 
approach on this topic.  
Additionally, you may refer to relevant U.S. and international standards, such as: 
  ANSI/AAMI HE 75:2009, Human factors engineeringDesign of medical devices. 
  ANSI/AAMI/IEC 62366:2007/(R) 2013, Medical devicesApplication of usability 
engineering to medical devices. 
A.   User Training and Certification 
When designing devices, you should take into account that users may not understand 
multiple steps, may receive minimal training or teaching on how to operate these devices, 
and may not be able to understand multiple warnings and precautions. In addition, users may 
not understand the need to calibrate, clean, and maintain the device. User training may be 
critical for safe operation of home use devices. 
We recommend that you consider the need for training as you determine the complexity of 
your home use device.  The content and time needed for successful training depends on 
factors specific to the device. We suggest you validate the effectiveness of your training 
program.  
For many devices, the user may also need a care partner to help operate the device safely and 
to provide monitoring of the patient while the device is being used.  We recommend that you 
outline the responsibilities of the care partner, the caregiver, and the care recipient during the 
training sessions and provide instructions to users on emergency procedures, such as the 
procedures necessary if a serious adverse event occurs.  We recommend that you provide 
guidance to the user on any retraining or recertification that is needed for safe operation of 
the device and indicate how frequently this needs to be done.  
FDA recommends that you review AAMI TIR49:2013, Design of training and instructional 
material for medical devices used in non-clinical environments.  
                                                           
9 Such testing may be subject to IDE requirements in section 520(g) of the FD&C Act and 21 CFR Part 812 and 
the human subject protection requirements in 21 CFR Parts 50 and 56 depending on the nature of the testing. 
10 Such a study may also be subject to the IDE and human subject protection requirements referenced above. 
  14  Contains Nonbinding Recommendations 
 
 
 
 
IX.   Labeling 
Labeling for home use devices must address all applicable requirements in 21 CFR Part 801 
and 809.10.  Labeling considerations should be for both prescription and OTC devices. In 
general, the IFU for the user should be simple, concise, and easily understood.  Instructions 
written for the user should be written in a narrative format, and pictures may be helpful to 
explain instructional steps.  Although instructions, labeling, and training can influence users 
to use devices safely and effectively, use of such material assumes that the user will 
remember or refer back to the information. These approaches are less effective than 
designing the system so that it is inherently apparent to users. The devices labeling should 
include contraindications that clearly explain why any individual should not use the device, 
and clear warnings of all hazards that cannot be designed out. Using the same terms 
throughout the labeling to identify the device avoids confusion for the user. Labeling on 
devices should be simple, visible, and clear and readily understood by the user; it should also 
be able to withstand defacement or wear. In addition to developing clear and effective 
labeling for the device, you should consider situations when the device may be separated 
from the labeling and what end users need to do to access the labeling, such as finding it on a 
Web site or calling someone who may be able to help them with safe device operation. 
In addition to the labeling requirements found in 21 CFR Part 801 and 809.10, you may 
obtain information for developing labeling for home use devices from the following 
documents:  
  Labeling of Home-Use In Vitro Testing Products: Approved Guideline, Clinical and 
Laboratory Standards Institute, GP-14 (June, 1996). 
  FDAs guidance Establishing Safety and Compatibility of Passive Implants in the 
Magnetic Resonance (MR) Environment (December 11, 2014). 
FDA recommends that implanted devices include labeling that encourages patients to 
register the conditions under which the implant can be scanned safely with the 
MedicAlert Foundation or equivalent organization.   
  FDAs Guidance on Medical Device Patient Labeling (April 19, 2001). 
  FDAs guidance Investigational Device Exemptions (IDE) for Devices Indicated for 
Nocturnal Home Hemodialysis (April 15, 2008).  
  Clause 5 of ISO 15197:2003, In vitro diagnostic test systems  Requirements for 
blood-glucose monitoring system for self-testing in managing diabetes mellitus. 
  15  Contains Nonbinding Recommendations 
 
A.   Handling the Device in an Emergency 
FDA recommends that manufacturers of life-supporting and life-sustaining care devices for 
the home have plans for providing emergency service and supplies during natural disasters 
and public health emergencies. You may refer to FDAs booklet Home Use Devices: How to 
Prepare for and Handle Power Outages for Medical Devices that Require Electricity (2011). 
The booklet provides information that a user should have in the event of a power outage, 
including a contact telephone number for the manufacturer.  The booklet advises the user that 
he or she keep all of his or her device information in one place that is readily accessible, such 
as on the refrigerator or on a device identification card that the user carries.  The booklet 
recommends that users contact their local power companies and their local social services 
departments to be put on lists for special attention when public health or safety emergencies 
happen.  The booklet also advises users to look for signs of damage to the device and how to 
identify the circumstances under which the device or its accessories should not be used.   
Refer to the following sources for additional information about handling the device in an 
emergency: 
  Department of Homeland Securitys Web site: Prepare for Emergencies Now: 
Information for People with Disabilities.  
  FDAs Web site about medical device safety in emergencies: FDA Offer Tips about 
Medical Devices and Hurricane Disasters. 
B.   Disposal  
The IFU should include information concerning the proper disposal of the device and its 
accessories. You should provide proper warnings and precautions regarding safe disposal of 
waste products when using the device in the home environment and help the user understand 
the difference between biological waste and regular waste. If the device or accessories 
require professional assistance to dispose of biological or biohazardous waste, the IFU 
should state that the user should make proper arrangements for safe waste disposal.  
C.   Hygienic Maintenance 
Home users do not have easy access to the cleaning, disinfecting, and sterilization supplies 
that are readily available in professional health care facilities. Ideally, home use devices 
should be designed to be cleaned, disinfected, or sterilized with readily available supplies and 
use simple techniques. If a home use device or its accessories require cleaning, disinfection, 
or sterilization prior to use, FDA recommends that you describe in the labeling for your 
device or system the complete cycles and methods for cleaning, sterilizing, or disinfecting 
the system.  FDAs guidance on this topic Reprocessing Medical Devices in Health Care 
Settings: Validation Methods and Labeling (March 17, 2015) represents FDAs approach on 
this topic.  
  16  Contains Nonbinding Recommendations 
 
If a medical device or its accessories require professional hygienic maintenance prior to re-
use, contact information for those services should be provided in the labeling and IFU. A 
technical description for hygienic maintenance requirements in the labeling and IFU should 
include methods to clean, disinfect, sterilize, rinse, dry, handle, and store the device before 
and after any type of service procedure, as well as indicate what steps are required if a device 
is transferred to another user.  The IFU should also cover how to obtain consumable or 
disposable supplies. 
For medical device reuse information written for the user, see FDA Offers Tips About 
Medical Devices and Hurricane Disasters: Reuse of Medical Devices. 
For more information on hygienic maintenance information on reprocessed single-use 
devices, see FDAs guidance Medical Device User Fee and Modernization Act of 2002, 
Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use 
Medical Devices (September 25, 2006).   
FDA also recommends that you refer to ANSI/AAMI HA60601-1-11:2011 section 7.5.2, 
Additional requirements for professional hygienic maintenance, in the design of medical 
devices. 
X.  Postmarket Considerations 
A.   Customer Service 
If you already have in place a toll-free technical assistance telephone number, email address,  
or Web site address for users regarding questions about use and maintenance of the device, or 
if the device is life-supporting or life-sustaining and you have a person available 24 hours a 
day to talk with users, it is important to keep these systems in place.  Information obtained 
through technical assistance is valuable data to be captured for analysis within your quality 
system.  
B.   Medical Device Reporting 
The Medical Device Reporting (MDR) regulation11 requires you to submit reports to the 
FDA whenever you become aware of information that reasonably suggests that a device you 
market may have caused or contributed to a reportable death or serious injury, or has 
malfunctioned and the malfunction would be likely to cause or contribute to a reportable 
death or serious injury should it recur.   
For the FDA Form 3500A, instructions for completing specific items on the form, and the 
coding manual see MedWatch: The FDA Safety Information and Adverse Event Reporting 
Program. 
                                                           
11 21 CFR Part 803 
  17  Contains Nonbinding Recommendations 
 
For additional guidance on the MDR regulation and the reporting requirements refer to 
FDAs guidance Medical Device Reporting for Manufacturers (March, 1997).  You should 
also see FDAs draft guidance Medical Device Reporting for Manufacturers (July 9, 2013).  
FDAs draft guidance represents FDAs proposed approach on this topic.    
XI. Conclusion 
By taking into consideration the physical environment, the user, the user interface, including 
device design, labeling and instructions for use, and by utilizing human factors, you can 
produce devices that suit the home use environment and are thereby more likely to provide 
reasonable assurance of safety and effectiveness for their intended use. By including 
descriptions of your efforts to take into account the various factors outlined in this guidance 
document in your premarket submissions, you can better assure that your devices meet 
applicable safety and effectiveness requirements. Designing your home use device in this 
manner should result in a safer and easier-to-use device, minimize use error, and reduce the 
likelihood that adverse events will occurthe preferred outcome of a well-designed medical 
device. 
  18  Contains Nonbinding Recommendations 
 
Appendix 1: List of References 
For the most recent version of a CDRH guidance, check the CDRH guidance web page at 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/de
fault.htm. 
1.   U.S. Food and Drug Administration. Center for Devices and Radiological Health.  
Standards Management Program. Available at: 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/defaul
t.htm or by calling 301-796-6574.  
    Standards Developing Organizations referred to in this guidance: 
  Association for the Advancement of Medical Instrumentation (AAMI) 
  ASTM (formerly known as American Society for Testing and 
Materials) 
  Clinical and Laboratory Standards Institute 
  International Electrotechnical Commission (IEC) 
  International Organization for Standardization (ISO) 
  The American National Standards Institute (ANSI) accredits the 
procedures of Standards Developing Organizations. 
Standards referenced in this guidance: 
  ANSI/AAMI/ISO14971:2007/(R)2010, Medical devicesApplication 
of risk management to medical devices.  
  IEC 62304 First edition 2006-05, Medical device software  Software 
life cycle processes and the identical standard ANSI/AAMI/IEC 
62304:2006.   
  ASTM D4169-09, Standard practice for performance testing of 
shipping containers and systems. 
  ANSI/AAMI ES60601-1:2012 (Edition 3.1), Medical electrical 
equipment  Part I: General requirements for basic safety and 
essential performance 
  ANSI/AAMI HA 60601-1-11:2011, Medical electrical equipment
Part 1-11: General requirements for basic safety and essential 
performanceCollateral standard: Requirements for medical 
electrical equipment and medical electrical systems used in the home 
healthcare environment. 
  ANSI/AAMI/IEC 60601-1-2 Edition 4:2014-02, Medical electrical 
equipment, Part 1-2: General requirements for basic safety and 
essential performance  Collateral standard: Electromagnetic 
disturbances  Requirements and tests.  
  19  Contains Nonbinding Recommendations 
 
  IEC 60601-1-8 Edition 2.1 2012-11, Medical electrical equipment; 
Part 1-8; General requirements for basic safety and essential 
performance; Collateral Standard: General requirements, tests and 
guidance for alarm systems in medical electrical equipment and 
medical electrical systems.   
  ANSI/AAMI HE75:2009, Human factors engineering--Design of 
medical devices. 
  ANSI/AAMI/IEC 62366:2007/(R)2013, Medical devicesApplication 
of usability engineering to medical devices. 
  AAMI TIR49:2013, Design of training and instructional material for 
medical devices used in non-clinical environments. (TIR=Technical 
Information Report) 
  Labeling of Home-Use In Vitro Testing Products: Approved Guideline, 
Clinical and Laboratory Standards Institute, GP-14 (June, 1996). 
  Clause 5 of ISO 15197:2003, In vitro diagnostic test systems  
Requirements for blood-glucose monitoring system for self-testing in 
managing diabetes mellitus. 
2.  Centers for Disease Control and Prevention. Emergency Preparedness and Response. 
Keep Food and Water Safe After a Disaster or Emergency. Available at:  
http://emergency.cdc.gov/disasters/foodwater/facts.asp
3.  U.S. Department of Homeland Security.  Transportation Security Administration. 
Travelers with Disabilities and Medical Conditions.  Available at: 
http://www.tsa.gov/traveler-information/travelers-disabilities-and-medical-conditions
4.  Design Control Guidance for Medical Device Manufacturers (March 11, 1997) 
Available at: 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocum
ents/ucm070627.htm  
5.  General Principles of Software Validation; Final Guidance for Industry and FDA 
Staff (January 11, 2002). Available at: 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocum
ents/ucm085281.htm  
6.  Guidance for the Content of Premarket Submissions for Software Contained in 
Medical Devices; Guidance for Industry and FDA Staff (May 11, 2005). Available at: 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocum
ents/ucm089543.htm 
7.  Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry 
and Food and Drug Administration Staff (August 13, 2013). Available at: 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocum
ents/ucm077210.htm  
  20  Contains Nonbinding Recommendations 
 
8.  Applying Human Factors and Usability Engineering to Medical Devices; Guidance 
for Industry and Food and Drug Administration Staff (February 3, 2016). Available 
at: http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-
gen/documents/document/ucm259760.pdf  
9.  Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance 
(MR) Environment; Guidance for Industry and FDA Staff (December 11, 2014). 
Available at: http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-
gen/documents/document/ucm107708.pdf  
10.   Guidance on Medical Device Patient Labeling: Final Guidance for Industry and FDA 
Reviewers (April 19, 2001).  Available at: 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocum
ents/ucm070782.htm  
11.  MedicAlert Foundation at http://www.medicalert.org  
12.  Investigational Device Exemptions (IDE) for Devices Indicated for Nocturnal Home 
Hemodialysis; Guidance for Industry and FDA Staff (April 15, 2008). Available at:  
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocum
ents/ucm071138.htm  
13.  U.S. Food and Drug Administration. Center for Devices and Radiological Health. 
Home Use Devices: How to Prepare for and Handle Power Outages for Medical 
Devices that Require Electricity, 2011. Available at: 
www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/HomeHeal
thandConsumer/UCM252812.pdf     
14.  U.S. Department of Homeland Security. Federal Emergency Management Agency 
(FEMA). Prepare for Emergencies Now: Information for People with Disabilities, 
FEMA R-6 Catalog No. 09774. Available at:  
  http://www.ready.gov/sites/default/files/FEMA_Disabilities_R-6_web_june2012.pdf
15.  U.S. Food and Drug Administration. Center for Devices and Radiological Health. 
FDA Offers Tips about Medical Devices and Hurricane Disasters at 
http://www.fda.gov/medicaldevices/safety/emergencysituations/ucm055987.htm
16.  U.S. Food and Drug Administration. Center for Devices and Radiological Health. 
FDA Offers Tips about Medical Devices and Hurricane Disasters: Reuse of Medical 
Devices. Available at: 
http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm055987.htm   
17.  Reprocessing Medical Devices in Health Care Settings: Validation Methods and 
Labeling; Guidance for Industry and FDA Staff (March 17, 2015) at 
http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-
gen/documents/document/ucm253010.pdf  
  21  Contains Nonbinding Recommendations 
 
18.  Medical Device User Fee and Modernization Act of 2002, Validation Data in 
Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical 
Devices; Guidance for Industry and FDA Staff (September 25, 2006) at 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocum
ents/ucm071434    
19.  U.S. Food and Drug Administration. MedWatch: The FDA Safety Information and 
Adverse Event Reporting Program: Reporting Serious Problems to FDA. Available at 
http://www.fda.gov/safety/medwatch/howtoreport/downloadforms/default.htm
20.  Medical Device Reporting for Manufacturers; Guidance for Industry and FDA Staff 
(March, 1997) at 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocum
ents/ucm094529.htm  
21.  Medical Device Reporting for Manufacturers; Draft Guidance for Industry and FDA 
Staff (July 9, 2013) at 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocum
ents/ucm359130.htm  
  22  Contains Nonbinding Recommendations 
 
Appendix 2: Additional Resources
 
1.  Ad Hoc Committee on Health Literacy for the Council on Scientific Affairs, 
American Medical Association, Health Literacy: Report of the Council on Scientific 
Affairs, JAMA, February 10, 1999  Vol 281, No 6. 
2.  California Department of Toxic Substances Control. UW for Residents-Batteries. 
Available at: http://dtsc.ca.gov/HazardousWaste/UniversalWaste/Res_Batteries.cfm 
3.  Consumer Product Safety Commission, 16 CFR Part 1501, Method for identifying 
toys and other articles intended for use by children under 3 years of age which present 
choking, aspiration, ingestion hazards because of small parts. 
4.  Mahadevan, R. Center for Health Care Strategies (CHCS), Health Care Literacy Fact 
Sheets, October 2013. Available at: http://www.chcs.org/resource/health-literacy-
fact-sheets/    
5.  Global Harmonization Task Force document SG1/N41:2005 Essential Principles of 
Safety and Performance of Medical Devices. 
6.  Institute of Medicine of the National Academies, Health Literacy: A Prescription to 
End Confusion (2004). Available at: 
http://www.nationalacademies.org/hmd/Reports/2004/Health-Literacy-A-
Prescription-to-End-Confusion.aspx  
7.  Keay, S. et al. The safe use of infusion devices.  Continuing Education in 
Anaesthesia, Critical Care & Pain (2004) 4 (3) 81-85. 
8.  National Research Council.  Health Care Comes Home: The Human Factors.  
Committee on the Role of Human Factors in Home Health Care, Board on Human-
Systems Integration, Division of Behavioral and Social Sciences and Education. 
Washington, DC: The National Academies Press, 2011. 
9.  RTCA DO-160G:2010, Environmental conditions and test procedures for airborne 
equipment.  (NOTE: RTCA, Inc. was originally founded in 1935 as the Radio 
Technical Commission for Aeronautics.) 
10. U.S. Environmental Protection Agency. Wastes-Non-Hazardous Waste-Industrial 
Waste: Where You Live  State Medical Waste Programs and Regulations.  Available 
at: http://www.epa.gov/osw/nonhaz/industrial/medical/programs.htm    
11. U.S. Environmental Protection Agency. Wastes-Resource Conservation-Common 
Wastes and Materials: Batteries. Available at: 
http://epa.gov/osw/conserve/materials/battery.htm
  23  Contains Nonbinding Recommendations 
 
12. U.S. Food and Drug Administration. Medical Devices. Device Advice: 
Comprehensive Regulatory Assistance. Available at: 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm
13. U.S. Food and Drug Administration. Center for Devices and Radiological Health. 
Home Use Devices. Available at: 
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthand
Consumer/HomeUseDevices/default.htm   
14. U.S. Food and Drug Administration. Center for Devices and Radiological Health.  
Human Factors and Medical Devices. Available at: 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HumanFactors/d
efault.htm  
15. U.S. Food and Drug Administration. Medical Device Reporting. Available at: 
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm
 
 
 
 
 
 
 
 
  24