On Tuesday, June 14, 2022, from 1 p.m. to 2:15 p.m. EDT, the FDA will host a webinar to discuss the Cybersecurity in Medical Devices: Quality System Considerations and Content Premarket Submissions draft guidance.
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The draft guidance replaces the 2018 draft version and is intended to further emphasize the importance of ensuring that devices are designed securely, enabling emerging cybersecurity risks to be mitigated throughout the Total Product Life Cycle, and to outline more clearly the FDA’s recommendations for premarket submission content to address cybersecurity concerns.
Submit public comments to the draft guidance under docket number FDA-2021-D-1158.
All legally-marketed medical devices have benefits and risks. The FDA clears, authorizes, and approves devices to be marketed when there is a reasonable assurance that the devices are safe and effective for their intended use.
Medical devices are increasingly connected to the Internet, hospital networks, and other medical devices to provide features that improve health care and increase the ability of health care providers to treat patients. These same features also increase potential cybersecurity risks. Medical devices, like other computer systems, can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device.
Threats and vulnerabilities cannot be eliminated and reducing cybersecurity risks is especially challenging. The health care environment is complex, and manufacturers, hospitals, and facilities must work together to manage cybersecurity risks.
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- Cybersecurity News and Updates
- Mitigating Cybersecurity Risks
- Cybersecurity Reports and White Papers
- Cybersecurity Guidances
- Cybersecurity Safety Communications and Other Alerts
- Reporting Cybersecurity Issues
- MOUs on Cybersecurity in Medical Devices
- Workshops and Webinars on Cybersecurity
- Other Collaborations on Cybersecurity
- FDA Cybersecurity New Releases
Incident Response Playbook: Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook is a playbook that describes the types of readiness activities that will enable health delivery organizations (HDOs) to be better prepared for a cybersecurity incident involving their medical devices and gives product developers more opportunity to address the potential for large scale, multi-patient impacts that may raise patient safety concerns.
Threat Modeling Playbook: Playbook for Threat Modeling Medical Devices is an educational resource that discusses best practices for understanding basic threat modeling concepts and processes, and how to apply them to medical devices.
Speaker series: The joint FDA and University of California San Francisco-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) is a speaker series of virtual one-hour lectures to promote regulatory science –including innovative research, education, and scientific exchange. It takes place monthly, on the third Thursday of each month from noon to 1:00 p.m. EST
Video: Cybersecurity Awareness for Connected Medical Devices offers practical steps patients can take to protect their device and personal information.
Paper: Best Practices for Communicating Cybersecurity Vulnerabilities for Patients outlines information for the FDA, federal partners, and industry stakeholders to help thoughtfully inform patients and the public about cybersecurity vulnerabilities
Medical device manufacturers (MDMs) and health care delivery organizations (HDOs) should take steps to ensure appropriate safeguards are in place.
- Medical device manufacturers (MDMs) are responsible for remaining vigilant about identifying risks and hazards associated with their medical devices, including risks related to cybersecurity.
- Health care delivery organizations (HDOs) should evaluate their network security and protect their hospital systems.
- Both MDMs and HDOs are responsible for putting appropriate mitigations in place to address patient safety risks and ensure proper device performance.
FDA Fact Sheet:
THE FDA'S ROLE IN MEDICAL DEVICE CYBERSECURITY
Dispelling Myths and Understanding
Download the Fact Sheet (PDF - 175kb)
|11/30/2021||Playbook for Threat Modeling Medical Devices||The Playbook for Threat Modeling is an educational resource for the medical device sector to learn how to effectively threat model. Many private and public sector organizations recommend threat modeling to help manage and respond to cyber threats and risks.|
|10/01/2021||Best Practices for Communicating Cybersecurity Vulnerabilities to Patients||This paper outlines information for the FDA, federal partners, and industry stakeholders to help thoughtfully inform patients and the public about cybersecurity vulnerabilities.|
|05/10/2021||NIST Request on Presidential Executive Order: Comments Submitted by the FDA (PDF - 4MB)||This paper provides relevant responses to the National Institute of Standards and Technology (NIST) call for position papers to fulfill the President’s Executive Order (EO) on Improving the Cybersecurity of the Federal Government (EO 14028), issued on May 12, 2021. It highlights existing FDA guidance documents and international standards on the science of cybersecurity for the premarket review of medical devices and post-market surveillance of cybersecurity incidents and vulnerabilities.|
|06/17/2021||Strengthening Cybersecurity Practices Associated with Servicing of Medical Devices: Challenges and Opportunities||The FDA released this discussion paper to consider cybersecurity issues that are unique to the servicing of medical devices and to seek input on these topics.|
|04/07/2022||Draft Guidance: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions||This draft guidance replaces the 2018 draft version and is intended to further emphasize the importance of ensuring that devices are designed securely, enabling emerging cybersecurity risks to be mitigated throughout the Total Product Life Cycle, and to outline the FDA’s recommendations more clearly for premarket submission content to address cybersecurity concerns.|
|10/18/2018||Draft Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices||Provides recommendations to industry regarding cybersecurity device design, labeling, and documentation to be included in premarket submissions for devices with cybersecurity risk.
When final, the recommendations are intended to supplement these guidance documents:
|12/27/2016||Final Guidance: Postmarket Management of Cybersecurity in Medical Devices||Provides recommendations to industry for structured and comprehensive management of postmarket cybersecurity vulnerabilities for marketed and distributed medical devices throughout the product lifecycle.|
|10/02/2014||Final Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices||
In addition to the specific recommendations contained in this guidance, manufacturers are encouraged to address cybersecurity throughout the product lifecycle, including during the design, development, production, distribution, deployment and maintenance of the device.
|01/14/2005||Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software||A growing number of medical devices are designed to be connected to computer networks. Many of these networked medical devices incorporate off-the-shelf software that is vulnerable to cybersecurity threats such as viruses and worms. These vulnerabilities may represent a risk to the safe and effective operation of networked medical devices and typically require an ongoing maintenance effort throughout the product life cycle to assure an adequate degree of protection. The FDA issued guidance to clarify how existing regulations, including the Quality System (QS) Regulation, apply to such cybersecurity maintenance activities.|
In each of the following cases, the FDA is not aware of any patient injuries or deaths associated with cybersecurity incidents, nor are we aware that any specific devices or systems in clinical use have been purposely targeted. However, left unpatched or otherwise mitigated, these vulnerabilities could allow unauthorized users to access, control, and issue commands to compromised devices, potentially leading to patient harm. Health care facilities can reduce the risk of unauthorized access by implementing recommendations in the safety communications and alerts listed below.
|Date||Safety Communication or Alert||Description|
|06/02/2022||Illumina Cybersecurity Vulnerability May Present Risks for Patient Results and Customer Networks: Letter to Health Care Providers||The U.S. Food and Drug Administration (FDA) is informing laboratory personnel and health care providers about a cybersecurity vulnerability affecting software in the Illumina NextSeq 550Dx, the MiSeqDx, the NextSeq 500, NextSeq 550, MiSeq, iSeq, and MiniSeq, next generation sequencing instruments.|
|03/08/2022||Cybersecurity Alert: Vulnerabilities identified in medical device software components: PTC Axeda agent and Axeda Desktop Server||
Cybersecurity Alert: Vulnerabilities identified in medical device software components: PTC Axeda agent and Axeda Desktop ServerThe FDA is alerting medical device users and manufacturers about a cybersecurity vulnerability identified for the Axeda agent and Axeda Desktop Server. The agent and desktop server are used in numerous medical devices across several medical device manufacturers and all versions of Axeda agent and Axeda Desktop Server are affected. On March 8, 2022, the Cybersecurity and Infrastructure Security Agency (CISA) published an advisory, ICSA-22-067-01, on these vulnerabilities.
The Axeda agent and Axeda Desktop Server are web-based technologies that allow one or more people to securely view and operate the same remote desktop, through the Internet. The Axeda agent and desktop server are owned and supported by the computer software company, PTC.
Successful exploitation of this vulnerability could allow an unauthorized attacker to take full control of the host operating system, resulting in full system access, remote code execution, read/change configuration, file system read access, log information access, and a denial-of-service condition. Depending on its use in the medical device, these vulnerabilities could result in changes to the operation of the medical device and impact the availability of the remote support functionality.
To mitigate the cybersecurity vulnerability, PTC recommends that affected manufacturers:
Upgrade the Axeda Desktop Server to Version 6.9 build 215. The Axeda agent loopback-only configuration is only available in Version 6.9.1 and above. Upgrading to Axeda agent 6.9.1 or above is required.
For additional questions about this vulnerability, medical device manufacturers should reach out to PTC.
|12/22/2021||Cybersecurity Alert: Fresenius Kabi Agilia Connect Infusion System||
On Tuesday, December 21, 2021, the Cybersecurity and Infrastructure Security Agency (CISA) published a vulnerability medical advisory ICSMA-21-355-01 on the Fresenius Kabi Agilia Connect Infusion System. Successful remote exploitation of these vulnerabilities could allow an attacker to gain access to sensitive information, modify settings, or perform arbitrary actions as an unauthorized user.
Affected components requiring a software security patch include:
Fresenius Kabi has created new versions to address these vulnerabilities. Fresenius Kabi also identified that approximatively 1,200 infusion pumps would need hardware changes. Until replacements can be made in customers’ installations, Fresenius Kabi recommends users rely on CISA’s recommendations for temporary alternatives. Health care delivery organizations are advised to follow the recommendations published by CISA and Fresenius Kabi to avoid cybersecurity risks that could affect the safety and essential performance of the Fresenius Kabi Agilia Connect Infusion System.
|12/17/2021||Cybersecurity Vulnerability with Apache Log4j||
The FDA is raising awareness of a cybersecurity vulnerability in Apache’s Log4j software library, versions 2.0-beta9 to 2.14.1.
Log4j is broadly used in a variety of consumer and enterprise services, websites, and applications—as well as medical devices and supporting systems—to log security and performance information. There is active, widespread exploitation of the vulnerability across various industries. These vulnerabilities may introduce risks for certain medical devices where the device could be made unavailable, or an unauthorized user could remotely impact the safety and effectiveness of device functionality. At this time, the FDA is not aware of any confirmed adverse events affecting medical devices related to these vulnerabilities.
The Cybersecurity and Infrastructure Security Agency (CISA) agency has established a website with additional information that the FDA encourages medical device manufacturers to review and follow the identified recommendations to address the vulnerability.
Manufacturers should assess whether they are affected by the vulnerability, evaluate the risk, and develop remediation actions. As Apache Log4j is broadly used across software, applications, and services, medical device manufacturers should also evaluate whether third-party software components or services used in or with their medical device may use the affected software and follow the above process to assess the device impact. Manufacturers who may be affected by this most recent issue should communicate with their customers and coordinate with CISA. As this is an ongoing and still evolving issue, we also recommend continued vigilance and response to ensure medical devices are appropriately secured.
Report any adverse events or suspected events through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. For more information, please see the guidance for manufacturers on medical device reporting.
|08/17/2021||CISA Alert: Cybersecurity Vulnerabilities with BlackBerry QNX||
The FDA is working closely with federal partners, medical device manufacturers, and the private sector to address cybersecurity vulnerabilities with BlackBerry’s QNX Real Time Operating System (RTOS) version 6.5 Service Pack 1 and earlier. These vulnerabilities may introduce risks for certain medical devices, as well as pharmaceutical or medical device manufacturing equipment. The FDA is not aware of any confirmed adverse events related to these vulnerabilities.
The FDA has provided information to medical device and pharmaceutical manufacturers on steps they should take to mitigate cybersecurity issues and actions to take when they believe a cybersecurity incident has occurred. Manufacturers are already assessing whether they are affected by these vulnerabilities, evaluating the risk, and developing remediation actions. Manufacturers who may be affected by this most recent issue should communicate with their customers and coordinate with the Cybersecurity and Infrastructure Agency (CISA).
|03/03/2020||SweynTooth Cybersecurity Vulnerabilities May Affect Certain Medical Devices||The FDA is informing patients, health care providers, and manufacturers about the SweynTooth family of cybersecurity vulnerabilities, which may introduce risks for certain medical devices.|
|01/23/2020||Cybersecurity Vulnerabilities in Certain GE Healthcare Clinical Information Central Stations and Telemetry Servers||The FDA is raising awareness among health care providers and facility staff that cybersecurity vulnerabilities in certain GE Healthcare Clinical Information Central Stations and Telemetry Servers may introduce risks to patients while being monitored.|
|10/01/2019||Urgent/11 Cybersecurity Vulnerabilities May Introduce Risks During Use of Certain Medical Devices||The FDA is informing patients, health care providers and facility staff, and manufacturers about cybersecurity vulnerabilities for connected medical devices and health care networks that use certain communication software.|
|06/27/2019||Certain Medtronic MiniMed Insulin Pumps Have Potential Cybersecurity Risks: FDA Safety Communication||The FDA has become aware of potential cybersecurity risks in certain Medtronic MiniMed Paradigm insulin pumps. The FDA recommends patients replace affected pumps with models that are better equipped to protect them from these potential risks.|
|03/21/2019||Cybersecurity Vulnerabilities Affecting Medtronic Implantable Cardiac Devices, Programmers, and Home Monitors: FDA Safety Communication||The FDA became aware of cybersecurity vulnerabilities identified in a wireless telemetry technology used for communication between Medtronic's implantable cardiac devices, clinic programmers, and home monitors. The FDA recommends that health care providers and patients continue to use these devices as intended and follow device labeling.|
|10/11/2018||Cybersecurity Updates Affecting Medtronic Implantable Cardiac Device Programmers||Medtronic released a software update to address the cybersecurity vulnerabilities associated with Medtronic's cardiac implantable cardiac device programmers.|
|04/17/2018||Battery Performance Alert and Cybersecurity Firmware Updates for Certain Abbott (formerly St. Jude Medical) Implantable Cardiac Devices||Abbott released an additional firmware update to address premature battery depletion and confirmed cybersecurity vulnerabilities identified in Abbott's (formerly St. Jude Medical) implantable cardiac devices|
|08/29/2017||Firmware Update to Address Cybersecurity Vulnerabilities Identified in Abbott's (formerly St. Jude Medical's) Implantable Cardiac Pacemakers||Abbott released a firmware update to address cybersecurity vulnerabilities identified in Abbott's (formerly St. Jude Medical) implantable cardiac pacemakers. The firmware update continues Abbott's efforts to mitigate confirmed vulnerabilities discovered by an independent research firm in 2016.|
|01/09/2017||Cybersecurity Vulnerabilities Identified in St. Jude Medical's Implantable Cardiac Devices and Merlin@home Transmitter||The FDA became aware of cybersecurity vulnerabilities in these devices after an independent research firm released information about these vulnerabilities.|
|05/13/2015||LifeCare PCA3 and PCA5 Infusion Pump Systems by Hospira - Security Vulnerabilities||The FDA and Hospira became aware of cybersecurity vulnerabilities in these infusion systems after an independent researcher released information about these vulnerabilities. On July 31 2015, Hospira and an independent researcher confirmed that it is possible to access the Symbiq Infusion System remotely through a hospital's network.|
|06/13/2013||Cybersecurity for Medical Devices and Hospital Networks||The FDA recommends that medical device manufacturers and health care facilities take steps to ensure that appropriate safeguards are in place to reduce the risk of device failure due to cyberattack.|
To receive safety communications on medical devices, including cybersecurity-related safety communications, subscribe to our Medical Devices Safety and Recalls emails.
As a part of our surveillance of medical devices on the market, the FDA monitors reports of cybersecurity issues with devices.
- Manufacturers, Importers, and Device User Facilities: See Medical Device Reporting (MDR) for details on mandatory reporting requirements.
- Health care providers: Use the MedWatch voluntary report form for health professionals (Form 3500) to report a cybersecurity issue with a medical device.
- Patients and caregivers: Use the MedWatch voluntary report form for consumers/patients (Form 3500B) to report a cybersecurity issue with a medical device.
The table below provides an overview of the cybersecurity information sharing agreements that the FDA has with various stakeholders to help us further protect and promote the public health.
|MOU 225-18-028||National Health Information Sharing & Analysis Center, Inc. (NHISAC) and MediSAO (information sharing analysis organization)||The goal of these Information Sharing and Analysis Organizations (ISAOs) is to provide manufacturers with the opportunity to share information about potential vulnerabilities and emerging threats with the FDA and to help manufactures protect patients by addressing those issues earlier.|
|MOU 225-18-030||Health Information Sharing & Analysis Center, Inc. (H-ISAC), formerly known as the National Health Information Sharing & Analysis Center, Inc. (NH-ISAC), and Sensato Critical Infrastructure ISAO||The goal of these ISAOs is to provide manufacturers with the opportunity to share information about potential vulnerabilities and emerging threats with the FDA and to help manufacturers protect patients by addressing those issues earlier.|
|MOA: DHS-FDA Medical Device Cybersecurity Collaboration||Department of Homeland Security (DHS)||The agreement implements a framework for greater coordination and information sharing about potential or confirmed medical device cybersecurity vulnerabilities and threats. This collaboration between the two agencies is intended to lead to better and more timely responses to potential threats to patient safety.|
|09/10/2019||Patient Engagement Advisory Committee Meeting: Cybersecurity in Medical Devices - Communication That Empowers Patients||
Provided background to the committee regarding the complexity of integrating medical device cybersecurity risk into health risk communications so that they can provide recommendations to the FDA on this topic.
Committee provided recommendations that:
|01/29-30/2019||Public Workshop: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices||Brought together diverse stakeholders to discuss, in-depth, the draft guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices and the sub-topic of the draft guidance regarding a Cybersecurity Bill of Materials (CBOM), which can be a critical element in identifying assets, threats, and vulnerabilities.|
|05/18-19/2017||Public Workshop: Cybersecurity of Medical Devices: A Regulatory Science Gap Analysis||Examined opportunities for FDA engagement with new and ongoing research; catalyzed collaboration among stakeholders to identify regulatory science challenges; discussed innovative strategies to address those challenges; and encouraged proactive development of analytical tools, processes, and best practices by the stakeholder community in order to strengthen medical device cybersecurity.|
|01/12/2017||Webinar: Postmarket Management of Cybersecurity in Medical Devices||Provided information about the guidance and opportunity to ask questions.|
|01/20-21/2016||Public Workshop, Moving Forward: Collaborative Approaches to Medical Device Cybersecurity||Highlighted past collaborative efforts and increased awareness of existing maturity models which are used to evaluate cybersecurity status, standards, and tools in development.|
|10/29/2014||Webinar: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices||Provided information about the guidance and opportunity to ask questions.|
|10/21-22/2014||Public Workshop: Collaborative Approaches for Medical Device and Healthcare Cybersecurity||Encouraged collaboration among stakeholders, identified challenges and discussed strategies and best practices for promoting medical device cybersecurity.|
International Medical Device Regulators Forum (IMDRF): The FDA serves as a co-chair of the IMDRF working group tasked with drafting a global medical device cybersecurity guide. The purpose of the guide is to promote a globally harmonized approach to medical device cybersecurity that at a fundamental level ensures the safety and performance of medical devices while encouraging innovation. The guide is thus intended to provide medical device cybersecurity advice for stakeholders across the device lifecycle on topics including but not limited to medical device cybersecurity terminology, stakeholders' shared responsibility, and information sharing. The finalized guide was published on March 18, 2020.
Healthcare and Public Health Sector Coordinating Council (HSCC): The FDA serves as a co-chair of the Government Coordinating Council (GCC) for the HPH HSCC. Specifically, this is a public-private partnership among healthcare industry leaders and the government to address the most pressing security and resiliency challenges to the healthcare sector as a whole including cybersecurity. As a co-chair of a task group within the HSCC cybersecurity working group, the FDA participated in the development of the Medical Device and Health IT Joint Security Plan (JSP). The JSP is a total product lifecycle reference guide to developing, deploying and supporting cybersecure technology solutions in the health care environment.
MITRE and MDIC Threat Modeling Bootcamps: In 2020, the FDA funded a series of threat modeling bootcamps, developed and hosted by MDIC and MITRE in partnership, to highlight the importance of threat modeling during the development, deployment, and maintenance of connected medical devices, and to provide training to industry representatives on threat modeling best practices and strategies. In addition to the bootcamps, the FDA has funded MDIC and MITRE to produce the Playbook for Threat Modeling Medical Devices, a threat modeling playbook that stakeholders throughout the sector may use to learn more about threat modeling best practices, and how to incorporate them into their own organizations and processes.
MITRE Corporation: In October 2018, the FDA supported the development of the MITRE Corporation's Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook. The playbook describes the types of readiness activities that will enable health delivery organizations (HDOs) to be better prepared for a cybersecurity incident involving their medical devices and gives product developers more opportunity to address the potential for large scale, multi-patient impacts that may raise patient safety concerns.
Medical Device Innovation Consortium (MDIC): In September 2018, as a member of an MDIC Steering Committee, the FDA supported the development of an MDIC's report Medical Device Cybersecurity Report: Advancing Coordinated Vulnerability Disclosure. The report encourages the adoption of coordinated vulnerability disclosure (CVD) policies by medical device manufacturers (MDMs) in an effort to promote medical device cybersecurity and patient safety. CVD policies establish formalized processes for obtaining cybersecurity vulnerability information, assessing vulnerabilities, developing remediation strategies, and disclosing the existence of vulnerabilities and remediation approaches to various stakeholders—often including peer companies, customers, government regulators, cybersecurity information sharing organizations, and the public. This report addresses the importance of CVD policies for MDMs and stakeholders across the medical device ecosystem.
- FDA in Brief: FDA Issues Draft Guidance on Remanufacturing and Discussion Paper Seeking Feedback on Cybersecurity Servicing of Medical Devices (June 17, 2021)
- FDA News Release: FDA Informs Patients, Providers and Manufacturers About Potential Cybersecurity Vulnerabilities in Certain Medical Devices with Bluetooth Low Energy (March 3, 2020)
- FDA News Release: FDA informs patients, providers and manufacturers about potential cybersecurity vulnerabilities for connected medical devices and health care networks that use certain communication software (October 1, 2019)
- FDA News Release: FDA warns patients and health care providers about potential cybersecurity concerns with certain Medtronic insulin pumps (June 27, 2019)
- FDA In Brief: FDA issues alert on potential premature battery depletion of certain Medtronic implantable pacemakers, approves related enhancements to device (May 7, 2019)
- FDA In Brief: FDA proposes updated cybersecurity recommendations to help ensure device manufacturers are adequately addressing evolving cybersecurity threats (October 17, 2018)
- FDA News Release: FDA and DHS increase coordination of responses to medical device cybersecurity threats under new partnership; a part of the two agencies' broader effort to protect patient safety (October 16, 2018)
- FDA In Brief: FDA warns patients, providers about cybersecurity concerns with certain Medtronic implantable cardiac devices (October 11, 2018)
- FDA Statement: FDA's efforts to strengthen the agency's medical device cybersecurity program as part of its mission to protect patients (October 1, 2018)
- FDA News Release: FDA outlines cybersecurity recommendations for medical device manufacturers (January 15, 2016)