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# Medical Device Cybersecurity Management Guidance
- URL: https://www.fdaweb.com/medical-device-cybersecurity-management-guidance/
- Published: 2017-01-03T12:00:00.000Z
- Updated: 2026-09-14T21:56:14.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137621

FDA has issued a guidance, *Postmarket Management of Cybersecurity in Medical Devices*, to inform industry of its recommendations for managing postmarket cybersecurity vulnerabilities for marketed and distributed medical devices. The [document](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM482022.pdf?ref=fdaweb.com) says that in addition to the specific recommendations in the guidance, manufacturers are encouraged to address cybersecurity throughout the product lifecycle, including during the design, development, production, distribution, deployment, and maintenance of the device.

The 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.

Contents include an introduction and background, guidance scope, definitions, general principles, medical device cybersecurity risk management, remediating and reporting cybersecurity vulnerabilities, recommended content to include in PMA periodic reports, and criteria for defining active participation by a manufacturer in an ISAO (information sharing analysis organization).