Contains Nonbinding Recommendations 
 
Design Considerations and Pre-
market Submission 
Recommendations for Interoperable 
Medical Devices  
Guidance for Industry and Food and 
Drug Administration Staff  
 
 
 
Document issued on: September 6, 2017 
The draft of this document was issued on January 26, 2016. 
For questions about this document regarding CDRH-regulated devices, email them to: 
DigitalHealth@fda.hhs.gov. 
For questions about this document regarding CBER-regulated devices, contact the Office of 
Communication, Outreach and Development (OCOD), by calling 1-800-835-4709 or 240-
402-8010. 
 
 
 
 
 
 
 
 
 
     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 electronic comments and suggestions at any time for Agency consideration to 
http://www.regulations.gov .  Submit written comments to the Dockets Management Staff, 
Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 
20852.  Identify all comments with the docket number [FDA-2015-4852]. 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 1500015 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, Room 3128, Silver Spring, MD 20993-
0002, or by calling 1-800-835-4709 or 240-402-8010, by email, ocod@fda.hhs.gov or from 
the Internet at 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/G
uidances/default.htm. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  Contains Nonbinding Recommendations 
 
Table of Contents 
I.  Introduction....................................................................................................................................................1
II.  Background...............................................................................................................................................2
III.  Scope.........................................................................................................................................................3
IV.  Definitions .................................................................................................................................................4
V. Design Considerations for Interoperable Medical Devices.......................................................................5
A.  Purpose of the Electronic Interface...........................................................................................................6
B.  Anticipated Users......................................................................................................................................7
C.  Risk Management Considerations .............................................................................................................8
D.  Verification and Validation Considerations ............................................................................................ 10
E.  Labeling Considerations .......................................................................................................................... 11
F.  Use of Consensus Standards .................................................................................................................... 12
VI.  Recommendations for Contents of Pre-market Submissions .................................................................. 12
A.  Device Description .................................................................................................................................. 13
B.  Risk Analysis ........................................................................................................................................... 14
C.  Verification and Validation ..................................................................................................................... 15
D.  Labeling ................................................................................................................................................... 16
 
 
  Contains Nonbinding Recommendations 
Design Considerations and Pre-
market Submission 
Recommendations for 
Interoperable Medical Devices 
 
 
Guidance for Industry and  
Food and Drug Administration Staff 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA 
or Agency) on this topic.  It does not establish any rights for any person and is not binding 
on FDA or the public.  You can use an alternative approach if it satisfies the requirements 
of the applicable statutes and regulations.  To discuss an alternative approach, contact the 
FDA staff or Office responsible for this guidance as listed on the title page.  
I.   Introduction  
As electronic medical devices are increasingly connected to each other and to other 
technology, the ability of these connected systems to safely and effectively exchange and use 
the information that has been exchanged becomes increasingly important.  Advancing the 
ability of medical devices to exchange and use information safely and effectively with other 
medical devices as well as other technology offers the potential to increase efficiency in 
patient care.   
FDA intends to promote the development and availability of safe and effective interoperable 
medical devices.  FDA is issuing this guidance to assist industry and FDA staff in identifying 
specific considerations related to the ability of electronic medical devices to safely and 
effectively exchange information and use exchanged information.  This document highlights 
considerations that should be included in the development and design of interoperable 
medical devices and provides recommendations for the content of premarket submissions and 
labeling for such devices.       
For the current edition of the FDA-recognized standard(s) referenced in this document, see 
the FDA Recognized Consensus Standards Database Web site at 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.  
  1  Contains Nonbinding Recommendations 
FDA recognizes and anticipates that the agency and industry may need up to 60 days to 
perform activities to operationalize the policies within the guidance.  If new information 
regarding device interoperability as outlined in this guidance is not included in a premarket 
submission received by FDA before or up to 60 days after the publication of this guidance, 
CDRH staff does not generally intend to request such information during the review of the 
submission.  CDRH does, however, intend to review any such information if submitted. 
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and 
should be viewed only as recommendations, unless specific regulatory or statutory 
requirements are cited.  The use of the word should in Agency guidance means that 
 
something is suggested or recommended, but not required. 
II.  Background  
The need and desire to connect medical devices to each other as well as other products, 
technologies and systems is growing in the healthcare community.  This interconnectivity of 
various products or systems that may include medical devices has been characterized by 
many as interoperability.1  Interoperability in healthcare has the potential to encourage 
innovation and facilitate new models of health care delivery by promoting the availability 
and sharing of information across systems even when products from different manufacturers 
are used.  
In this guidance we refer to interoperability as the ability of two or more products, 
technologies or systems to exchange information and to use the information that has been 
exchanged.  In this context, exchange of information includes transmission, reception or 
both, regardless of the means or protocol by which the exchange happens.  The use of the 
exchanged information can include displaying, storing, interpreting, analyzing, and 
automatically acting on or controlling another product.  When medical devices are involved 
in an interoperable system (a system of connected devices in which information is exchanged 
and used across the connections and which includes at least one medical device), the safety 
of the patient and operator are the most important considerations.   
Systems that include interoperable medical devices may be composed of existing devices, 
products, or technologies acting together to achieve a function different from the 
individual medical device.  Medical devices may be standalone, may broadcast data so 
anyone can access the data, may connect and exchange information with other medical 
devices, non-medical device technologies, and systems, or may be incorporated in a 
complex system of medical devices and/or non-medical device technologies.  Increased 
use of interoperable medical devices has the potential to foster rapid innovation at lower 
                                                           
1See Institute of Electrical and Electronics Engineering (IEEE) Standard Computer Dictionary: A Compilation 
of IEEE Standard Computer Glossaries (New York, NY: 1990).   
  2  Contains Nonbinding Recommendations 
cost.  However, appropriate safety considerations including those at the system level that 
are not taken into account in the device design can result in unforeseen safety and 
effectiveness issues for the patient, operator, device or system. 
Medical device interoperability is not limited to unidirectional patient data but includes 
more complex interactions, such as exerting command and control over a medical 
device(s).  Establishing and implementing appropriate functional, performance, and 
interface requirements for devices with such interactions is important.  One way to 
achieve this is through use of standardized architectures and communication protocols. 
Another way is to specify non-standard interface requirements and characteristics in 
labeling. 
Device design elements that factor in interoperability considerations may improve data 
portability and patient safety.  However, errors stemming from inadequate 
interoperability can occur, such as the transmission of weight in kilograms when the 
receiving medical device assumes the measurement is in pounds, and could lead to 
patient harm and even death. Therefore the failure to establish and implement appropriate 
functional, performance, and interface requirements during product development may 
lead to the exchange of inaccurate, untimely, or misleading information.  It may also lead 
to device malfunction, including the failure to operate, and could lead to patient injury 
and even death. 
Device-specific identification information, such as UDI (unique device identifier), and 
patient-specific data, such as ECG (electrocardiogram) waveforms, can contribute 
importantly to patient care and improved patient outcomes.  In addition, such information 
and data may be used, in conjunction with authoritative data sources like the Global 
Unique Device Identification Database (GUDID) to populate electronic health records 
and allow patients, their families, and health care providers to make better informed 
healthcare decisions.  FDA has taken steps to facilitate the use of medical device data and 
promote safe and effective interoperability.  For example, FDA has recognized various 
consensus standards that support medical device interoperability.  
This guidance is intended to highlight the following items that medical device manufacturers 
should consider to provide a reasonable assurance of safety and effectiveness of their 
interoperable medical devices: 1) designing systems with interoperability as an objective; 2) 
conducting appropriate verification, validation and risk management activities; and 3) 
specifying the relevant functional, performance, and interface characteristics in a user-
available manner such as labeling. 
III.  Scope 
This guidance provides manufacturers with design considerations when developing 
interoperable medical devices, and recommendations regarding information to include in pre-
market submissions and device labeling.  
  3  Contains Nonbinding Recommendations 
This document focuses on the information content exchanged over the connections (e.g., 
USB (Universal Serial Bus), wireless connection).  This document does not focus on aspects 
of physical compatibility such as physical connectors, but does recommend that 
manufacturers specify the type of connection that supports the electronic interface. 
This document is not intended to provide guidance on whether or not a specific product or 
modification to a product requires a pre-market submission.  We intend this document to 
complement other FDA guidance documents. 
The pre-market discussion within this guidance applies to the following premarket 
submissions for interoperable medical devices;2 
  Premarket Notification (510(k)) including Traditional, Special, and Abbreviated 
510(k) submissions; 
  De novo requests;  
  Premarket Approval Applications (PMAs); 
  Product Development Protocols (PDPs); 
  Humanitarian Device Exemption (HDE) submissions; and 
  Biologics License Applications (BLAs).  
IV.  Definitions 
Electronic interface: 
For purposes of this guidance, the electronic interface is the medium by which systems 
interact and/or communicate with each other thereby allowing the exchange of information 
between systems.  It includes both the type of connection (e.g. USB port, wireless 
connection) and the information content.  It is a medium by which a medical device 
exchanges and uses information with other equipment or other medical devices. 
Interoperable medical devices: 
For purposes of this guidance, interoperable medical devices are devices as defined in section 
201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that have the ability to 
exchange and use information through an electronic interface with another medical/non-
medical product, system, or device.  Interoperable medical devices can be involved in simple 
unidirectional transmission of data to another device or product or in more complex 
interactions, such as exerting command and control over one or more medical devices.  
Interoperable medical devices can also be part of a complex system containing multiple 
medical devices. 
 
                                                           
2 Manufacturers may also consider applying this guidance as appropriate to Investigational Device Exemption 
(IDE) submissions, Investigational New Drug (IND) submissions, and to devices exempt from premarket 
review.  For studies in which the primary purpose of the IDE study includes the interaction of two or more 
devices, the sponsor may wish to consider the recommendations within this guidance document. 
  4  Contains Nonbinding Recommendations 
V.  Design Considerations for Interoperable Medical 
Devices 
Manufacturers can choose from many design solutions to create interoperable medical 
devices.  The information model (data attributes), the functional model (role played within 
the interoperable system), and the architectural model (how the device is connected within 
the system) should be considered during the design and development of an interoperable 
medical device.  Design inputs should include the desired functional and performance 
characteristics of the electronic interface.   
  
Manufacturers of interoperable medical devices should perform a risk analysis and conduct 
appropriate testing that considers the risks associated with interoperability, the anticipated 
users, reasonably foreseeable misuse, and reasonably foreseeable combinations of events that 
can result in a hazardous situation.     
As a general matter, one action manufacturers can take to reduce risk and facilitate safe and 
effective interoperability is to clearly set forth in device labeling the functional and 
performance requirements of their electronic interface.  Providing these characteristics along 
with limitations of the interface or use of the device in an interoperable system can minimize 
the risks associated with failure to exchange and use data as intended.   
As part of a comprehensive quality system under 21 CFR part 820, medical device 
manufacturers must manage risks including those associated with an electronic interface 
that is incorporated into the medical device.  The following considerations should be 
appropriately tailored to the selected interface technology, and the intended use and use 
environments for the medical device.  
1.  Purpose of the Electronic Interface: Device manufacturers should consider 
the purpose for each of the electronic interfaces.  This should include the types 
of data exchanges taking place (e.g., sending, receiving, issue command and 
control).   
2.  The Anticipated Users: Manufacturers should determine the anticipated 
user(s) for each of the electronic interfaces.  Examples of users include: 
clinical user, biomedical engineers, home healthcare user, IT (information 
technology) professional, system integrator, system designers, patients, 
researchers, and medical device designers.  
3.  Risk Management: Manufacturers should consider ways to mitigate risks 
identified in the risk analysis.  This includes risks that arise from others 
connecting to the electronic interface.   
  5  Contains Nonbinding Recommendations 
4.  Verification and Validation: Manufacturers should establish, maintain, and 
implement appropriate verification and validation to ensure that their devices 
with electronic interfaces work correctly prior to delivery, during the 
integration process, continue to work while in use, and through maintenance 
and release of software updates. 
5.  Labeling Considerations: Manufacturers should include information that 
users may need to connect predictably and safely to the interface for its 
intended purpose. 
6.  Use of Consensus Standards: Manufacturers should consider the use of 
consensus standards related to medical device interoperability. 
A.  Purpose of the Electronic Interface 
Manufacturers should, as part of their device design, clearly establish the purpose of 
electronic interfaces that are included on a medical device and consider that purpose when 
they are both designing the device (including the electronic interface) and developing the 
device instructions.  There may be times when the purpose of the interface is included in the 
intended use and other times when the purpose of the interface plays a much smaller role and 
is not included in the intended use. 
In designing a medical devices electronic interface, manufacturers should consider the level 
of interoperability3 needed to achieve the purpose of the interface, as well as the information 
necessary to describe the interface.  The labeling should be in sufficient detail to allow 
anticipated users to connect and use the medical device and interface as it is intended.   
  
Design considerations may be different for different kinds of electronic interfaces.  An 
interface intended to deliver an electrical pulse for synchronization purposes has different 
requirements compared to an interface that delivers information to an information system.  
Elements that should be considered in the design of the devices electronic interface include 
but are not limited to the following:  
  types of devices that it is meant to connect to; 
                                                           
3 As a reference the concept of Levels of interoperability are described by others as follows: 
  Turnitsa, C.D. (2005). Extending the Levels of Conceptual Interoperability Model.  Proceedings IEEE 
Summer Computer Simulation Conference, IEEE CS Press. 
  Healthcare Information and Management System Society (HiMMS) Dictionary of Healthcare Information 
Technology Terms, Acronyms and Organizations, 2nd Edition, 2010, Appendix B, p190, original source: 
HIMSS Electronic Health Record Association. 
  M. Robkin, S. Weininger, B. Preciado and J. Goldman, "Levels of conceptual interoperability model for 
healthcare framework for safe medical device interoperability," Product Compliance Engineering (ISPCE), 
2015 IEEE Symposium on, Chicago, IL, 2015, pp. 1-8. 
  6  Contains Nonbinding Recommendations 
  type of data exchange taking place (e.g., sending, receiving, issue command 
and control); 
  the use of standards (e.g., data format, transmission, interface standards, 
standard terminologies);  
  the need for time synchronization4; 
  method of data transmission; 
  the necessary timeliness and the reliability of information (e.g., sample rate, 
transmission rate); 
  what the user should or should not do with the electronic interface including 
contraindications, warnings and precautions on the use of the exchanged 
information; 
  clinical context for the use of the information exchanged in the interface, such 
as an infusion pump used to deliver anesthesia to a sedated patient in the 
intensive care unit; 
  interoperability scenarios for the use of the interface, i.e., how the 
manufacturer anticipates the interface being used.  For example an interface 
on a pulse oximeter is used to send data to a computer system in an eight hour 
study on neonates to assess sleep.  The computer system is also gathering 
information from ECG.  Therefore the information from the pulse oximeter 
and ECG need to have their times synchronized and data collected at a 
specific rate.  Knowing the scenario would demonstrate the need for specific 
features;   
  the functional and performance requirements of the device as a result of the 
exchanged information; 
  expected flow of information or exchange of information through an 
application programming interface (API) which may include considerations of 
acceptable and unacceptable commands on the interface and impact of such 
interface on the device safety and effectiveness; and 
  the transmission of metadata (e.g., unique device identifier (UDI), software 
version, configurations, settings). 
B.  Anticipated Users 
It is important to identify not just the purpose of the electronic interface, but also the 
anticipated users of the electronic interface.  Determining the anticipated users will help in 
appropriately applying risk management strategies for activities such as developing 
appropriate instructions for use and setting limitations for use of the device, including 
contraindications, warnings and precautions.  Manufacturers should identify the anticipated 
user(s) for their device and how the device is expected to be used in the interoperable system.  
The manufacturer should make sufficient information available so that the anticipated user(s) 
                                                           
4 For time synchronization, one should consider using (RFC 1305) Network Time Protocol Version 3 or (RFC 
5905) Network Time Protocol Version 4, or another appropriate protocol. 
  7  Contains Nonbinding Recommendations 
can use the electronic interface safely and effectively.  Different types of users may need 
different information.  For example:  
  users, operators, and clinicians need to know the clinical uses and potential 
risks relevant to the use environment and the clinical task at hand; 
  equipment maintenance personnel and hospital clinical engineers need to 
know what actions to take to verify correct configuration and operation.  They 
need to assure that the system is performing as specified;  
  IT professionals need to understand the performance needs and security 
requirements of the devices connected to the networks they maintain and 
operate; 
  system integrators, system designers, and medical device designers are 
responsible for the safe and effective operation of their systems or devices and 
need to know the capabilities of the components they use so that they can 
perform adequate risk management and validation; and 
  patients may need specific instructions on how to use their device in a home 
environment. 
Manufacturers should consider the different users when they are both designing the device 
(including the electronic interface) and developing the device instructions.  These 
considerations may influence whether the manufacturer places certain limitations on the 
users of the device or limitations on how the device may be used.  Developing different 
instructions for different users may help to mitigate the risks.  
Manufacturers risk management strategies should address the risks associated with the 
anticipated users of the device, reasonably foreseeable misuse of the device, and reasonably 
foreseeable combinations of events that could result in a hazardous situation.  However, FDA 
recognizes that a manufacturer cannot be responsible for all possible uses outside of the 
purpose of the interface.  Based upon the risks associated with reasonably foreseeable use 
and misuse, a manufacturer may want to change the design of the device, the intended 
interoperability scenarios, or include warnings, precautions or contraindications in device 
labeling to reduce risks to acceptable levels.      
C.  Risk Management Considerations 
Including an electronic interface on a medical device may have an impact on risk 
management considerations including security for the medical device, the network, and other 
interfaced devices.  Analysis of risks due to both the intended and unintended access of the 
medical device through the interface should be considered.  FDA recognizes that managing 
interoperable medical devices includes balancing how to allow intended access while 
implementing security features to restrict unintended access to the medical devices.5 
                                                           
5 For more information on cybersecurity, please see our guidance, Content of Premarket Submissions for 
Management of Cybersecurity in Medical Devices available at: 
 
  8  Contains Nonbinding Recommendations 
FDA recommends that manufacturers include in their risk management approach a particular 
focus on the potential hazards, safety concerns, and security issues introduced when 
including an electronic interface.  For example, as part of the evaluation and design process, 
manufacturers should consider the following:   
  whether implementation and use of the interface degrades the basic safety or 
risk controls of the device;  
  whether implementation and use of the interface/interfaces degrades the 
essential performance of the device as defined in IEC 60601-1;  
  whether appropriate security features are included in the design; and 
  whether the device has the ability to handle data that is corrupted or outside 
the appropriate parameters. 
Note that this list is not intended to be a comprehensive list of the issues that a manufacturer 
should address for its individual medical device.  Manufacturers should conduct their own 
assessment and address the issues identified during their risk management activities.   
In addition, existing communication and interoperability standards can be useful in deciding 
what issues or concerns should be addressed in the risk analysis of an electronic interface.   
FDA believes that an interoperable system should maintain basic safety and essential 
performance during normal and fault conditions.  A manufacturer should design an 
interoperable medical device that can appropriately mitigate risks associated with possible 
error scenarios such as:6 
  failures or malfunctions caused by direct or indirect connection of intended 
devices; 
  failures or malfunctions caused by invalid commands; 
  failures or malfunctions caused by receiving and processing erroneous data or 
commands; and 
  failures or malfunctions caused by not adhering to the non-functional requirements of 
the communication specification.  By non-functional requirements, FDA refers to the 
examples listed in ASTM 2761-09(2013)(e.g., bandwidth, latency, time 
synchronization).   
Medical device manufacturers should complete a risk assessment of their connection that 
considers reasonably foreseeable uses and misuses.  The manufacturer should ensure that the 
risks are mitigated.  For complex systems that contain multiple medical devices, identifying 
                                                                                                                                                                                    
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM356
190.pdf 
6 See Section 5.4 of ASTM 2761-09 (2013), Medical Devices and Medical Systems - Essential safety 
requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: 
General requirements and conceptual model. 
  9  Contains Nonbinding Recommendations 
and managing the risks can be quite complicated.  To address complex systems containing 
multiple medical devices, manufacturers should use a systems approach as well as apply the 
considerations listed within this section.   
As part of their risk management process consistent with 21 CFR part 820, a manufacturer 
should establish, document, and maintain throughout the medical device lifecycle an ongoing 
process for identifying hazards, estimating and evaluating the associated risks, controlling 
these risks, and monitoring the effectiveness of the controls.  This process should include risk 
analysis, risk evaluation, risk control, and incorporation of production and post-production 
information.  FDA recognizes that medical device interoperability is a shared risk among 
stakeholders, including health care facilities, patients, providers, and manufacturers of 
medical devices.  Manufacturers should have a defined process to systematically conduct a 
risk evaluation and determine whether a risk is acceptable or unacceptable.  It is not possible 
to describe all hazards and risks associated with medical device interoperability in this 
guidance.  One example is the risks associated with unforeseen use of an interface by a third 
party.  FDA recommends manufacturers define and document their process for objectively 
assessing the foreseeable use and reasonably foreseeable misuse of their medical device 
throughout the device lifecycle. 
D.  Verification and Validation Considerations 
The verification and validation warranted will depend on the level of risks associated with 
the device, the purpose of the interface, the anticipated use of the device in the target system, 
and the intended use of the device.  
Interoperable medical devices should undergo an appropriate level of testing to demonstrate 
that the interactions on the electronic interface perform as intended.  The medical device 
manufacturer should test the electronic interface based upon the purpose of the interface and 
should make sure that it complies with the intended specifications.  For devices meant to be 
used with a limited number of specific devices, appropriate testing demonstrating safe 
operation with those specific devices may be appropriate.  For devices meant to work with 
many devices, it may be appropriate to test the device against the interface specification and 
with representative devices for verification.  If the medical device is meant to be a part of a 
larger interoperable system, the manufacturer should conduct testing to reasonably assure 
that the medical device will continue to safely and effectively fulfill its intended use when it 
is assembled, installed, and maintained according to its instructions.   
For example, a manufacturer should:   
  verify and validate that when data is corrupted it can be detected and 
appropriately managed;    
  perform testing to assure that the device continues to operate safely when data 
is received in a manner outside of the bounds of the parameters specified.  
Determine how or whether this can be detected and what impact this will have 
on the rest of the system; 
  10  Contains Nonbinding Recommendations 
  implement a fault-tolerant design and verify its performance; 
  establish and specify fail safe states for critical functions (e.g., delivering 
energy, real-time monitoring); 
  if conforming to consensus standards, verify and validate that the design 
meets the intent and scope identified in the standards; 
  verify only authorized users (individuals, devices and systems) are allowed to 
exchange information with the interoperable medical device; 
  validate the user(s) interface.  Determine that the user(s) are capable of 
correctly using the interface(s); 
  assure that reasonably foreseeable interactions do not cause incorrect 
operation of other networked systems; and 
  conduct testing that simulates real-world use of the device.   
As part of the specification for an interoperable medical device, the manufacturer should also 
consider developing appropriate test scenarios which may allow a user to assess if the basic 
safety and effectiveness of the medical device is maintained when incorporated into the 
intended interoperable system. 
E.  Labeling Considerations 
One way to reduce risk and facilitate safe and effective medical device interoperability is to 
include in labeling the functional and performance requirements of the electronic interfaces 
that may be used to connect medical devices with other electronic equipment.7  Labeling 
options may include materials within the packing of the device, the instructions for use, or 
device-specific information posted on the manufacturers web site.  The manufacturer should 
determine the appropriate way to provide the information based upon the anticipated users 
and the risk analysis. 
                                                           
7 Section 201(k) of the FD&C Act defines 'label' as a:  
  'display of written, printed, or graphic matter upon the immediate container of any article...' 
The term 'immediate container' does not include package liners.  Any word, statement, or other information 
appearing on the immediate container must also appear 'on the outside container or wrapper, if any there be, or 
the retail package of such article, or is easily legible through the outside container of wrapper.' 
Section 201(m) defines 'labeling' as: 
  'all labels and other written, printed, or graphic matter 
(1) upon any article or any of its containers or wrappers, or 
(2) accompanying such article' at any time while a device is held for sale after shipment or delivery for 
shipment in interstate commerce. 
The term 'accompanying' is interpreted liberally to mean more than physical association with the product.  It 
extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, fillers, 
etc.  ' Accompanying' also includes labeling that is brought together with the device after shipment or delivery 
for shipment in interstate commerce. 
  11  Contains Nonbinding Recommendations 
Even if a device is not subject to pre-market submission, the recommendations found in 
Section VI.D, which gives labeling recommendations for pre-market submissions, may be 
helpful to develop clear labeling and minimize risk.   
F.  Use of Consensus Standards 
FDA recognizes the benefits of relying on published consensus standards in the design of 
medical devices, in general, and in the development of interoperable medical devices, in 
particular.  As such, FDA has recognized numerous consensus standards relevant to the 
development and design of interoperable medical devices and encourages their use.  In many 
cases, the standards that support interoperability may be used by not only manufacturers of 
medical devices, but also many other stakeholders such as healthcare delivery organizations, 
including system integrators, system designers, and information technology professionals 
who work in health care settings.   
Many of the currently available standards that support medical device interoperability are 
design standards.  These standards may help manufacturers with other design considerations 
identified above.  For example, standards may specify data format, interoperability 
architecture design, or other aspects associated with interoperability.  Conformance with 
recognized consensus standards is voluntary for a medical device manufacturer.  FDA 
recognition of design standards does not mean that FDA is recommending a particular design 
standard over another.  FDA recognition of design standards that support interoperability are 
meant to encourage manufacturers, health care organizations, and others to implement 
interoperability in a standardized way.  Alternatively, manufacturers may choose to use their 
own design preferences for their interface (in lieu of a published consensus standard) for their 
medical devices.  In either case, problems or misuse of interoperable medical devices can be 
minimized by making the functional, performance, and interface requirements openly 
available to all users.   
FDA continues to evaluate standards that support interoperability of medical devices for 
recognition.  In addition, FDA welcomes recommendations of published consensus standards 
for consideration of recognition 
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123739.
htm). Please refer to the FDA Recognized Consensus Standards Database for a current listing 
of recognized standards 
(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm). 
 
VI.  Recommendations for Contents of Pre-market 
Submissions 
Not all interoperable medical devices require premarket submission to the FDA.  This section 
provides guidance for those interoperable medical devices that require a premarket 
  12  Contains Nonbinding Recommendations 
submission.  The premarket submission may just cover one device that is part of the intended 
interoperable system or may cover the whole system. 
When preparing a premarket submission, consider any other relevant FDA guidances or 
special controls applicable to the device.  For a medical device that is intended to 
exchange and use information with or from another product, technology, or system, FDA 
recommends that sponsors provide basic information similar to what would normally be 
provided to support other functions or features on a medical device.  Specifically, when 
considering the presence of an electronic interface, we recommend considering the 
elements that were discussed in the Design Considerations for Interoperable Medical 
Devices section of this document.  As with any submission, when making a claim that a 
device exchanges and uses information with or from other devices, technologies, or 
products, the information submitted should be sufficient to support the claim.   
A.  Device Description 
As part of the device description typically submitted in a premarket submission, a 
sponsor should include a discussion of each externally-facing electronic interface found 
on the device, the purpose of each interface, and the anticipated users of the interface.  
Sponsors should also describe how each interface is meant to be used and/or the 
limitations of the use of the interfaces.  If the interface is only meant to be used by the 
manufacturer, this should be clearly stated.  If the interface is meant to be used with only 
specific devices, those devices should be clearly specified.   
If the device is meant to exchange or use data with or from other medical devices, 
products, technologies, or systems, then the device description should include a 
description of the information exchanged, how it is exchanged, and the impact the 
exchanged information has on the device or other impacted devices.  This may include 
some or all of the following elements based upon the claims of data exchange and use 
made for the medical device:  
  explain the purpose of the interface and the role the device plays within an 
interoperable system.  This may be as simple as stating that the device is 
meant to deliver device data to a specific product, technology, or system 
architecture described in a particular standard;   
  specify if the interface is meant to transmit, receive, or exchange 
information;   
  specify any standards used including relevant version numbers and dates. 
  describe the requirements for timeliness and the integrity of the 
information (e.g. sample rate, transmission rate); 
  describe the communication format, rate, and transmission method; 
  discuss the limitations (what the user should not do), contraindications, 
precautions, and warnings; 
  describe the functional and performance requirements; and 
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  list the Application Programming Interface (API) if the device is software 
that can be used by other software, medical device or system. 
Please note that the level of detail necessary may depend upon the intended interoperable 
scenario(s) in which the manufacturer expects the interoperable medical device to be 
used. 
B.  Risk Analysis 
Manufacturers risk analysis should consider the risks associated with interoperability, 
reasonably foreseeable misuse, and reasonably foreseeable combinations of events that 
could result in a hazardous situation.   Based upon these risks, a manufacturer may want 
to change the design of the device, the intended interoperability scenarios, or include 
device limitations and/or warnings to reduce risks to acceptable levels.  As discussed in 
ISO 14971, risk control measures may not be necessary for risks that are broadly 
acceptable;8 these decisions should be captured within the risk analysis documentation.   
FDA emphasizes that the same process of defining hazardous situations, risks, and 
mitigations can be used when considering a system that contains more than one 
connected medical device.  There may be additional hazardous situations that arise in 
these conditions.  The manufacturer should specify which mitigations are implemented 
and which are necessary for safe use but may require implementation by other parties, 
such as the party responsible for set-up or installation.  These should be included in the 
risk analysis section of the submission. 
For devices subject to the risk analysis in 21 CFR 820.30(g), FDA recommends including 
an analysis of the interface or interfaces on the devices, the intended connections, and any 
effects that the connection may have on the device performance.  The normal risk 
analysis submitted should include hazards that were considered, possible hazardous 
situations, the risks that may result from each, and how the hazards and risks were 
addressed.  Your submitted analysis should include the normal elements in a risk analysis 
and address: 
  the risk control measures for reducing unacceptable risks to acceptable 
levels;  
  fault tolerant behavior, boundary conditions, and fail safe behavior such as 
how the device handles delays, corrupted data, data provided in the wrong 
format, unsynchronized or time mismatched data, and any other issues 
with the reception and transmission of data; 
  any risks potentially arising from security vulnerabilities9 that may be 
                                                           
8 ISO 14971:2007, Medical devices -- Application of risk management to medical devices. 
9 For additional information on cybersecurity in medical devices, please see our guidance document, Content 
of Premarket Submissions for Management of Cybersecurity in Medical Devices available at: 
 
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involved with the presence of an electronic interface; and 
  risks arising from normal use as well as reasonably foreseeable misuse.  
For example, a manufacturer may want to include in the labeling an 
explicit warning against foreseeable uses that could result in harm.  
It is important to note that there are a variety of methods including assurance cases that 
can be used to capture information on risk and how it is addressed in the design and 
implementation of a device.  This document does not specify which method should be 
used; rather it emphasizes the need to capture this information.   
C.  Verification and Validation 
As part of the device performance testing typically submitted in a pre-market submission, 
a sponsor should include results of verification and validation testing for the electronic 
interfaces on the device.  The nature and extent of the validation depends upon the risks 
associated with the device, the purpose of the interface, the anticipated use of the device 
in the interoperable system, and the intended use of the device.  Manufacturers should 
consider aspects highlighted in section V.D. under design considerations. 
For those devices that are only meant to be used with a limited number of specific 
devices, documentation demonstrating appropriate testing with those specific devices 
may be appropriate.  For those devices meant to connect with a class of devices or to be 
used by any device or computer system, documentation demonstrating appropriate testing 
with a representative of that class of devices or within the context of the system may be 
more appropriate.  Documentation which demonstrates the following performance testing 
should be included in the submission: 
  verification that the device interface meets its design specifications; 
  validation that the device interface performs as intended; 
  determination and verification of the information that should be provided 
to a user to connect to the interface and to allow the user to ensure that the 
connection has been made correctly; and 
  verification that the device will perform safely and within specification 
when used under normal conditions and abnormal conditions that are 
reasonably likely to occur (e.g. receives data outside of specification, 
connected to an unintended device or system, does not lock up the system 
when the interface is exercised). 
The degree of documentation can vary based upon the risks associated with the device, 
                                                                                                                                                                                    
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM356
190.pdf and 
Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) 
Software available at: 
http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm077812.htm.  
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the purpose of the interface, the anticipated use of the device in the interoperable system, 
and the intended use of the device.  For those elements of the interface that use a 
standard, demonstrating conformance to that standard may be sufficient10.  For example, 
if the purpose of the interface along with the intended scenarios for use of the interface do 
not add significant risk to the operation of the medical device, then test summaries may 
be sufficient.   
The following examples describe situations in which different levels of documentation 
have been determined appropriate for submission to FDA; one in which complete test 
reports should be submitted and another when only a testing summary should be 
submitted. 
  If an infusion pump is intended to receive patient data from several 
devices (e.g., a pulse oximeter, ventilator, and blood pressure monitor) and 
use this data to change infusion pump settings, complete test reports 
should be provided to the FDA in the planned submission; and 
  If a non-invasive blood pressure monitor has an interface intended to 
allow historical data to be downloaded to a computer, then a summary of 
the testing performed on the interface may be sufficient. 
D.  Labeling 
The following recommendations are intended to help prepare labeling that satisfies the 
requirements of 21 CFR parts 801 and 809, as appropriate.  Note that labeling must 
comply with the requirements of 21 CFR parts 801 and 809, as appropriate, before a 
medical device is introduced into interstate commerce.11  For additional information on 
developing labeling, please consult FDA Guidance: Labeling - Regulatory Requirements 
for Medical Devices 
(http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guidanc
eDocuments/UCM095308.pdf)  
Information regarding the electronic interface on the device should be included in the 
labeling, so that the device can be used safely and effectively for its intended uses.  This 
information should enable users to connect to the device in the specified manner, and 
should give proper instruction on how to use the connection to the device in the ways for 
which it was designed.  Manufacturers should also include in labeling any limitations of 
the connection to discourage any misuse of the device.  Precautions, warnings and 
                                                           
10 To determine the appropriate amount of documentation to support conforming to a standard, see the guidance 
document, Guidance for Industry and FDA Staff - Recognition and Use of Consensus Standards, 
http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm077274.htm.   
11 Devices with approved BLAs may also be subject to certain labeling requirements in 21 CFR parts 610 and 
660. 
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contraindications should be included in device labeling as well.  Validation of labeling 
regarding the use of the electronic interface should consider human factors12 as 
appropriate.  
If the device is meant to interact with only a few specific devices, the labeling should 
explicitly state that the medical device is meant to connect with the specific devices listed 
(including the version) and that it should not be used with other medical devices or non-
medical device technologies.  If the interface is only meant to be used by the 
manufacturers technicians for software updates or diagnostics, this should be explicitly 
stated in the labeling.  When appropriate, the labeling should include instructions that the 
electronic interfaces found on the device are not meant for connecting to other medical 
devices or non-medical device technologies and that use of the electronic interface is 
reserved for representatives of the manufacturers.  
FDA recommends that the following information be included in the device labeling as 
appropriate, based on the purpose of the medical device interface: 
  the purpose of the interface including any devices, device types, interface 
standard/specification, or software (including the version of the software) with 
which it is meant to connect;  
  the anticipated user(s); 
  whether the connection is meant to control the operations of another device; 
  specifications for each interface (e.g., physiological waveforms, probe type, 
accuracy, frequency of response, update rate, data rate, bandwidth), as well as 
the necessary performance and functional requirements from the device 
related to the sending or receiving of data/control; 
  list of the data attributes being exchanged; 
  summary of the testing performed on the interfaces to verify interoperability 
claims and any activities suggested for the user to verify safe operation.  In the 
case where testing was performed to an interface specification and verified 
with a representative device, the manufacturer should specify the 
representative device used; 
  relevant standards used and certifications received; 
  any method used for time synchronization; 
  a description of any fault tolerance behavior, boundary condition testing, or 
fail safe for critical functions (e.g., delivering energy) that will allow the user 
to understand how to use the interface correctly; 
  any known limitations (what the user should not do), contraindications, 
precautions and warnings; 
                                                           
12 For more information please refer to the FDA guidance, Applying Human Factors and Usability Engineering 
to Medical Devices available at: http://www.fda.gov/downloads/MedicalDevices/.../UCM259760.pdf 
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  recommended connections; 
  recommended settings, or configurations for the electronic interface; and 
  instructions for specific users such as IT personnel on how to connect or 
install and disconnect or uninstall the device.  
 
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