FDA Cybersecurity Guidance

FDA Guidance for Industry: Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software, Issued on: January 14, 2005

The guidance was developed by the FDA to clarify how existing regulations, including Quality System (QS) Regulation, apply to such cybersecurity maintenance activities. The guidance outlines general principles that FDA considers application to software maintenance actions required to address cybersecurity vulnerabilities for networked medical devices – specifically, those that incorporate OTS software.

Content of Premarket Submission for Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff, issued on October 2, 2014

The guidance was developed by the FDA to assist industry by identifying issues related to cybersecurity that manufacturers should consider in the design and development of their medical devices as well as in preparing premarket submissions for those devices.

http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm356190.pdf

The recommendations contained in this guidance document are intended to supplement FDA’s “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089543.htm)
and “
Guidance to Industry: Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software
(
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077812.htm).

Distinguishing Medical Device Recalls from Medical Device Enhancements

Guidance for Industry and Food and Drug Administration Staff, issued on October 15, 2014

This guidance is intended to: (1) clarify when a change to a device constitutes a medical device recall, (2) distinguish those instances from device enhancements that do not meet the definition of a medical device recall, and (3) clarify reporting requirements under 21 CFR part 806.

http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm418469.pdf

Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”), Issued December 14, 2016

This FDA guidance describes the Center for Devices and Radiological Health (CDRH) policy for notifying the public about medical device “emerging signals,” which is defined in the guidance as new information about a marketed medic device: 1) that supports a new causal association or an new aspect of a known association between a devices and an adverse event or set of adverse events, and 2) for which the Agency has conducted an initial evaluation and determined that the information has the potential to impact patient management decisions and/or the known benefit-risk profile of the device.