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# Medical Device Cybersecurity Guidance Outlined
- URL: https://www.fdaweb.com/medical-device-cybersecurity-guidance-outlined/
- Published: 2017-01-17T12:00:00.000Z
- Updated: 2026-09-14T22:00:30.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137743

Ropes & Gray attorneys say that medical device manufacturers should review a recent FDA final guidance on postmarket management of medical device cybersecurity and consider how to incorporate its recommendations into their postmarket management activities. In an online [regulatory alert](https://www.ropesgray.com/newsroom/alerts/2017/01/FDA-Finalizes-Guidance-on-Postmarket-Management-of-Medical-Device-Cybersecurity.aspx?ref=fdaweb.com), the attorneys say that FDA recommends that manufacturer cybersecurity risk management programs include: 

- monitoring cybersecurity information sources for identification and detection of cybersecurity vulnerabilities and risks;
- maintaining robust software lifecycle processes including mechanisms for monitoring third-party software components for new vulnerabilities and performing design validation for software updates and patches used to remediate vulnerabilities;
- understanding assessing and detecting vulnerabilities;
- establishing and communicating processes for cybersecurity vulnerability intake and handling;
- using threat modeling to define how to maintain safety and essential performance of a device by developing mitigations that protect, respond, and recover from a cybersecurity risk;
- adopting a coordinated vulnerability disclosure policy and practice; and
- deploying mitigations that address cybersecurity risk early and before exploitation.

The alert says the final guidance differs from an earlier draft in three important respects: 

- uses the potential for patient harm, rather than risk to the safety and effectiveness of the device itself, as the touchstone for assessing risks posed by cybersecurity vulnerabilities;
- extends to 60 days the time that device manufacturers have to remediate an uncontrolled risk while remaining subject to FDA’s enforcement discretion policy for reporting a device correction, provided that the manufacturer communicates interim controls to its customers and the user community within 30 days after learning of the vulnerability; and
- provides additional details and guidance to manufacturers on a number of subjects.

Device manufacturers that have not already done so should consider conducting a comprehensive assessment of their cybersecurity practices and procedures,” Ropes & Gray says, “taking into account the recommendations in the FDA pre- and post-market guidance documents and third-party standards, and evaluate whether to become an active participant in an ISAO (information sharing analysis organization).”