To mark the FDA cyber team’s 10-year anniversary, here is an infographic showing some of the ways they have contributed to patient safety over the past decade.
Medical devices can be vulnerable to cybersecurity threats, potentially impacting the safety and effectiveness of the device.
Medical device cybersecurity is the process of preventing unauthorized access, modification, misuse, denial of use, or unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient, such as the patient or health care provider. Designing cybersecurity into medical devices from the beginning increases their ability to be cybersecure over the Total Product Life Cycle (TPLC).
The FDA’s Medical Device Cybersecurity division, within the Center for Devices and Radiological Health (CDRH), develops recommendations to improve medical device cybersecurity and responds to medical device cybersecurity vulnerabilities and incidents. We collaborate with public and private groups to advance medical device cybersecurity.
Resources and Updates Cybersecurity
- June 27, 2025 – The FDA issued the final guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. This guidance added Section VII to address FDA’s recommendations regarding section 524B of the FD&C Act for cyber devices. This document supersedes the final guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” issued September 27, 2023
- October 24, 2024 – The FDA contracted with MITRE to develop the Data Normalization Challenges and Mitigations in Software Bill of Materials (SBOM) Processing white paper. The publication discusses normalization challenges and mitigations for generating and digesting SBOMs, and advantages of using a standard nomenclature and formats to ensure that data from various sources is consistent.
- March 13, 2024 – The FDA issued the draft guidance Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act. This draft guidance proposed updated recommendations to industry on cybersecurity considerations for cyber devices and documentation in device premarket submissions.
- November 15, 2023 – The FDA contracted with MITRE to develop the report, Next Steps Toward Managing Legacy Medical Device Cybersecurity Risks. This publication outlines practical approaches that may help drive sector-wide legacy device cyber risk management efforts.
- September 27, 2023 – The FDA issued the final guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. This guidance provided recommendations on medical device cybersecurity considerations and premarket submissions.
- May 1, 2023 – The FDA launched its third video: Tips for Health Care Facilities: Cybersecurity Incident Preparedness and Response. The video focuses on how to prepare for a cybersecurity event and help ensure patient safety during a prolonged cybersecurity event.
For more information about cybersecurity in medical devices, we recommend you consult our guidance documents and read Cybersecurity in Medical Devices Frequently Asked Questions (FAQs).
Safety Communications and Alerts Related to Cybersecurity
Unless otherwise noted in the description, the FDA is not aware of any patient injuries or deaths associated with these cybersecurity alerts. However, left unpatched or otherwise mitigated, these vulnerabilities may potentially lead 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 | Cybersecurity Safety Communication or Alert | Description |
|---|---|---|
| 01/30/2025 | Cybersecurity Vulnerabilities with Certain Patient Monitors from Contec and Epsimed: FDA Safety Communication | The FDA issued a safety communication to raise awareness about cybersecurity vulnerabilities in Contec CMS8000 patient monitors and Epsimed MN-120 patient monitors. These medical devices are used in health care and home settings for displaying information, such as the vital signs of a patient, including temperature, heartbeat, and blood pressure. |
| 09/20/2022 | Medtronic MiniMed 600 Series Insulin Pump System Potential Cybersecurity Risk | Medtronic MiniMed 600 Series Insulin Pump System Potential Cybersecurity Risk. The FDA is alerting medical device users about a cybersecurity risk for the Medtronic MiniMed 600 Series Insulin Pump System (for example: MiniMed 630G and MiniMed 670G). There is a potential issue associated with the communication protocol for the pump system that could allow unauthorized access to the pump system. Medtronic issued an Urgent Medical Device Correction to inform medical device users of this cybersecurity risk and included actions and recommendations for users to take. |
| 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 | Vulnerabilities identified in medical device software components: PTC Axeda agent and Axeda Desktop Server. The FDA is alerting medical device users and manufacturers about a cybersecurity vulnerability identified for the Axeda agent and Axeda Desktop Server. On March 8, 2022, the Cybersecurity and Infrastructure Security Agency (CISA) published an advisory, ICSA-22-067-01, on these vulnerabilities. |
| 12/22/2021 | Cybersecurity Alert: Fresenius Kabi Agilia Connect Infusion System | 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. |
| 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. 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. |
| 08/17/2021 | Cybersecurity Alert: 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. |
Review previous Cybersecurity Safety Communications and Other Alerts on the FDA’s web archive.
Report a medical device cybersecurity issue
Cybersecurity Resources for Medical Device Users/Patients
Cybersecurity Resources for Manufacturers of Medical Devices
Medical Device Cybersecurity Collaborations
Contact the FDA’s Medical Device Cybersecurity Division
- For help reporting a medical device cybersecurity vulnerability or incident, as well as for questions related to the FDA’s cybersecurity policies, or the cybersecurity section of the eSTAR template, email us at Cybermed@fda.hhs.gov.
- For device specific cybersecurity questions, submit a pre-submission through the FDA’s Q-submission program.
