Medical device manufacturers are already assessing which devices may be affected by SweynTooth and are identifying risk and remediation actions. In addition, several microchip manufacturers have already released patches. For more information about SweynTooth cybersecurity vulnerabilities – including a list of affected devices, see ICS-ALERT-20-063-01 SweynTooth Vulnerabilities, Department of Homeland Security Cybersecurity Infrastructure Security Advisory.

The agency is asking medical device manufacturers to communicate to health care providers and patients which medical devices could be affected by SweynTooth and ways to reduce associated risk. Patients should talk to their health care providers to determine if their medical device could be affected and to seek help right away if they think their medical device is not working as expected.


The FDA takes reports of vulnerabilities in medical devices very seriously and today’s safety communication includes recommendations to manufacturers for continued monitoring, reporting and remediation of medical device cybersecurity vulnerabilities. The FDA is recommending that manufacturers conduct a risk assessment, as described in the FDA’s cybersecurity postmarket guidance, to evaluate the impact of these vulnerabilities on medical devices they manufacture and develop risk mitigation plans. Medical device manufacturers should work with the microchip manufacturers to identify available patches and other recommended mitigation methods, work with health care providers to determine any medical devices that could potentially be affected, and discuss ways to reduce associated risks.

The FDA will continue to assess new information concerning the SweynTooth vulnerabilities and will keep the public informed if significant new information becomes available.

Further, the FDA will continue its ongoing work with manufacturers and health care delivery organizations—as well as security researchers and other government agencies—to help develop and implement solutions to address cybersecurity issues throughout a device's total product lifecycle.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Back to HCB News

Health IT Homepage