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Design Considerations and Pre-market 

Submission Recommendations for 

Interoperable Medical Devices 

Final Guidance

Heather Agler, Ph.D.

Senior Science Health Advisor

Office of the Center Director

Center for Devices and Radiological 

Health
3 

Agenda

• Overview of the Guidance

I. Key Definitions

II. Introduction

III. Background and Scope

IV. Design Considerations

V. Pre Market Submission Content

• Q & A
4 

Key Definitions

• Interoperable medical devices: devices that have 

the ability to exchange and use information 

through an electronic interface with another 

medical/nonmedical 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.
5 

Key Definitions

• Electronic Interface: 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. 
6 

Purpose of the Guidance

• To promote the availability of safe and effective 

interoperable medical devices.

• To provide considerations to use in the 

development and design of interoperable 

medical devices.

• To clarify the contents to submit in a pre-market 

submission to support interoperable medical 

devices.

• To provide recommendations for labeling.
7 

FDA’s Involvement in Medical 

Device Interoperability

FDA hosted the Second Meeting of the 

Medical Device PNP Interoperability Project

Recognized a set of standards that 

supports Interoperable Medical Devices

FDA, CDC, NLM, ONC, and CMS Workshops on 

Promoting Semantic Interoperability of Lab Data

2004

2013

2015

2016

Draft Guidance 2017

Final Guidance

2012

FDA/AAMI Summit on Medical 

Device Interoperability

2010

FDA/Continua/CIMIT Medical Device 

Interoperability Workshop 

PNP: Plug-and-Play

CIMIT: Consortia for Improving Medicine with Innovation and Technology

AAMI: Association for the Advancement of Medical Instrumentation 

CDC: Centers for Disease Control

NLM: National Library of Medicine

ONC: Office of the National Coordinator

CMS: Center for Medicare and Medicaid Services
8 

Benefits of Interoperable Medical Devices

Interoperable medical devices have the potential to:

• foster new innovative healthcare solutions at lower 

cost.

• foster information-sharing between devices and 

systems and across manufacturers.
9 

Use of Interoperable Medical Devices

• Information from medical devices can be used to:

– display or store information

– interpret or analyze information

– automatically act on or control another product

• 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
10

Considerations for Medical Device

Manufacturers 

• Designing systems with interoperability as an objective

• Conducting appropriate verification, validation and risk 

management activities

• Specifying the relevant functional, performance, and 

interface characteristics in a user available manner 

such as labeling
11

Guidance Scope

• Provides manufacturers with: 

– design considerations when developing interoperable medical devices

– recommendations regarding information to include in pre-market 

submissions

– device labeling

• This document focuses on the information content exchanged over 

connections (e.g., USB, wireless connection). It does not focus on 

aspects of physical compatibility. 

• 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 for this document to complement other FDA 

guidance documents.
12

Guidance Scope

• The pre-market discussion within this guidance 

applies to the following premarket submissions for 

interoperable medical devices

– 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

– Biologics License Applications (BLAs) 
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Design Considerations for Developing 

Interoperable Devices 

The following considerations should be 

appropriately tailored to the selected interface 

technology, and the intended use and use 

environments for the medical device.

• The Purpose of the Electronic Interface

• The Anticipated Users

• Risk Management

• Verification and Validation

• Labeling Considerations

• Use of Consensus Standards
14

Purpose of the Electronic Interface

• Device manufacturers should consider the purpose for each of 

the electronic interfaces. 

• Manufacturers should consider the level of interoperability 

needed to achieve the purpose of the interface, as well as the 

information necessary to describe the interface.

• Design considerations may be different for different kinds of 

electronic interfaces. 
15

Elements that should be considered include, but are not limited to 

the following: 

• types of devices that it is meant to connect to

• type of data exchange taking place

• the use of standards

• the need for time synchronization

• method of data transmission

• necessary timeliness and reliability of information

• method of data transmission

• limitations or contraindications

• clinical context

• anticipated use of the interface

• the functional and performance requirements of the device

Purpose of the Electronic Interface
16

The Anticipated Users

• Manufacturers should determine the 

anticipated user(s) for each of the electronic 

interfaces. 

• 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.
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Manufacturers should consider the different users when designing the device 

and developing the instructions. 

• 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 may need to know the capabilities of the components so 

that they can perform adequate risk management and validation.

• Patients may need specific instructions on how to use their device in a home 

environment.

The Anticipated Users
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• In addition to expected users, manufacturers 

should also consider malicious users or attackers in 

the design of the device.

• 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.

The Anticipated Users
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Risk Management

• Consider both intended and unintended access through the 

interface. 

• Balance how to allow intended access while implementing security 

features to restrict unintended access to the medical devices.

• Consider reasonably foreseeable uses and misuses of the 

electronic interface.

• Develop an ongoing process for identifying hazards, estimating and 

evaluating the associated risks, controlling these risks, and 

monitoring the effectiveness of the controls over the lifecycle of 

the device.
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Cybersecurity

20
21

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.

Risk Management
22

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:

• 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). 

Risk Management
23

• The verification and validation considerations 

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

– The intended use of the device 

• Testing should demonstrate that the interactions 

on the electronic interface perform as intended 

and complies with the intended specifications. 

Verification and Validation
24

• For devices meant to be used with a limited number of 

specific devices, appropriate testing to demonstrate safe 

operation with those specific devices. 

• 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. 

• For devices 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.

Verification and Validation
25

Verification and Validation

Appropriate testing may include:

• 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;

• Establish and specify fail safe states for critical functions (e.g., delivering 

energy, real-time monitoring);

• Verifying only authorized users (individuals, devices and systems) are allowed 

to exchange information with the interoperable medical device;

• Validating the user interface(s). Determining that the user(s) are capable of 

correctly using the interface(s);

• Assuring that reasonably foreseeable interactions only cause correct operation 

of other networked systems and nothing else; and

• Testing that simulates real-world use of the device.
26

Labeling

• Labeling should contain the functional, interface, and performance 

requirements of the electronic interfaces that may be used to connect medical 

devices with other electronic equipment.

• Labeling may include materials within the packaging of the device, the 

instructions for use, or device-specific information posted on the 

manufacturer’s web site. 

• There may be different directions for different users.

• Further recommendations can be found in the “Content for Pre-Market 

Submissions” section of this guidance.
27

Use of Consensus Standards

• FDA encourages the use of consensus standards to support medical device 

interoperability. 

• Standards that support interoperability are for manufacturers and other stakeholders 

such as healthcare delivery organizations, system integrators, system designers, and 

information technology professionals who work in health care settings.

• 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.

• FDA welcomes recommendations of published consensus standards for consideration of 

recognition 

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123

739.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
28

Content of Pre-market Submissions

• This section provides guidance for those interoperable 

medical devices that require a premarket submission.

• For a medical device intended to exchange and use 

information with or from another product, technology, or 

system, FDA recommends sponsors provide basic information 

similar to what would normally be provided to support other 

functions or features on a medical device. 

• Please note: 

– There may be FDA guidances or special controls applicable to the 

device. 

– Some device specific standards may contain interface specification 

recommendations.
29

• As part of the normal device description, a sponsor 

should discuss each externally-facing electronic interface.

• 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.

• Please note that the level of detail may depend upon the 

intended interoperable scenario(s) in which the 

manufacturer expects the interoperable medical device 

to be used.

Device Description
30

The description of the electronic interface may include some or all of the 

following elements based upon the claims of data exchange and use made for 

the medical device:

• the purpose of the interface and the role the device plays within an 

interoperable system.

• if the interface is meant to transmit, receive, or exchange information;

• standards used;

• requirements for timeliness and the integrity of the information (e.g. sample 

rate, transmission rate);

• communication format, rate, and transmission method;

• limitations (what the user should not do), contraindications, precautions, and 

warnings;

• functional and performance requirements; and

• the Application Programming Interface (API) if the device is software that can 

be used by other software, medical device, or system.

Device Description
31

• 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. 

• As discussed in ISO 14971, risk control measures may not be 

necessary for risks that are broadly acceptable.

• There may be additional hazardous situations that arise when 

more than one medical device is connected within a system.

• 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.

Risk Analysis
32

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. 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;

• any risks potentially arising from security vulnerabilities that may be 

involved with the presence of an electronic interface; and

• risks arising from normal use as well as reasonably foreseeable misuse. 

Risk Analysis
33

• A sponsor should include results of verification and validation testing 

for the electronic interfaces. 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.

• For devices only meant to be used with a limited number of specific 

devices, documentation demonstrating appropriate testing with those 

specific devices may be appropriate. 

• For 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. 

Verification and Validation
34

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.

Verification and Validation
35

The degree of documentation can vary based upon the risks. 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.

Examples:

• 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.

• 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.

Content of Pre-market Submissions: 

Verification and Validation
36

Content of Pre-market Submissions: 

Labeling

• 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. 

• 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. 

• This should include any limitations of the connection to discourage 

any misuse of the device. 

• Precautions, warnings, and contraindications should be included in 

device labeling as well. 

• Validation of labeling regarding the use of the electronic interface 

should consider human factors as appropriate.
37

Labeling 

Scenario 1: 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 nonmedical 

device technologies. 

Scenario 2: The interface is only meant to be used by the manufacturer’s 

technicians for software updates or diagnostics. It should be explicitly 

stated in the labeling that the use of the electronic interface is reserved 

for representatives of the manufacturers. 

Scenario 3: The device is not meant to be interoperable. The labeling 

should state that the electronic interfaces found on the device are not 

meant for connecting to other medical devices or non-medical device 

technologies. 
38

Labeling 

Scenario 4: If the electronic interface is meant to interact with other 

medical devices, the guidance lists a series of items to consider placing in 

your labeling. 

• Consider whether certain information is needed for someone to 

properly connect to your device through the electronic interface and 

use the information as described.

• Consider what information is appropriate based on the risk associated 

the device, the purpose of the interface, the anticipated use of the 

device in the interoperable system, and the intended use of the 

device. 

• Consider the use of standards for the electronic interfaces.

 
39

Labeling 

FDA recommends 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 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; 
40

Labeling 

FDA recommends the following information be included in the device labeling as appropriate, 

based on the purpose of the medical device interface (continued):

• 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;

• 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.
41

Medical Device Interoperability

Digital Health related questions: DigitalHealth@fda.hhs.gov
Questions?

For questions related to the guidance document, please contact the Digital Health 

Team: digitalhealth@fda.hhs.gov

 

For general questions, please contact the Division of Industry and Consumer 

Education: DICE@fda.hhs.gov 

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