Contains Nonbinding Recommendations
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.
The Food and Drug Administration (FDA) is issuing this guidance to inform industry and FDA staff of the Agency’s recommendations for managing postmarket cybersecurity vulnerabilities for marketed and distributed 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 device1 . A growing number of medical devices are designed to be networked to facilitate patient care. Networked medical devices, like other networked computer systems, incorporate software that may be vulnerable to cybersecurity threats. The exploitation of vulnerabilities may represent a risk to health and typically requires continual maintenance throughout the product life cycle to assure an adequate degree of protection against such exploits. Proactively addressing cybersecurity risks in medical devices reduces the overall risk to health.
This guidance clarifies FDA’s postmarket recommendations and emphasizes that manufacturers should monitor, identify, and address cybersecurity vulnerabilities and exploits as part of their postmarket management of medical devices. This guidance establishes a risk-based framework for assessing when changes to medical devices for cybersecurity vulnerabilities require reporting to the Agency and outlines circumstances in which FDA does not intend to enforce reporting requirements under 21 CFR part 806. 21 CFR part 806 requires device manufacturers or importers to report promptly to FDA certain actions concerning device corrections and removals. However, the majority of actions taken by manufacturers to address cybersecurity vulnerabilities and exploits, referred to as “cybersecurity routine updates and patches,” are generally considered to be a type of device enhancement for which the FDA does not require advance notification or reporting under 21 CFR part 806. For a small subset of actions taken by manufacturers to correct device cybersecurity vulnerabilities and exploits that may pose a risk to health, the FDA would require medical device manufacturers to notify the Agency. Risks to health posed by the device may result in patient harm. This guidance recommends how to assess whether the risk4 of patient harm is sufficiently controlled or uncontrolled. This assessment is based on an evaluation of the likelihood of exploit, the impact of exploitation on the device’s safety and essential performance, and the severity of patient harm if exploited.
This document is not intended to provide guidance on reporting to FDA when a device has or may have caused or contributed to a death or serious injury as required by section 519 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Medical Device Reporting (MDR) Regulation in 21 CFR part 803. For an explanation of the current reporting and recordkeeping requirements applicable to manufacturers of medical devices, please refer to the Medical Device Reporting for Manufacturers Guidance
For the current edition of the FDA-recognized standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database Web site at
FDA’s guidance documents, including this final 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.