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The need for effective cybersecurity to ensure medical device functionality and safety has become more important with the increasing use of wireless, Internet and network connected devices, portable media (flash memory, microdrive, hard drive or SSD drive), and the frequent electronic exchange of medical device-related health information.

Cybersecurity threats to the healthcare sector have become more frequent, more severe, and more clinically impactful. Related incidents have rendered medical devices and hospital networks inoperable, disrupting the delivery of patient care across healthcare facilities in the United States and around the world.

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Premarket Submissions for Medical Devices Containing a Software

In order to demonstrate a reasonable assurance of safety and effectiveness, documentation related to the software validation and risk analysis, is often a necessary part of the premarket submission.

Software device manufacturers may need to establish a cybersecurity vulnerability and management approach, where appropriate, for devices that contain software (including firmware) or programmable logic, as well as software that is a medical device (collectively referred to as “software devices”).

Effective cybersecurity management is intended to decrease the risk of patient harm by reducing device exploitability, which can result in intentional or unintentional compromise of device safety and essential performance.

The requirements of the Quality System Regulation (QSR) apply to the following applications:

As part of QSR design controls, manufacturers must establish and maintain procedures for validating the devices design, which include software validation and risk analysis.

  • Premarket Notification 510(k) including Traditional, Special, and Abbreviated
  • De Novo requests
  • Premarket Approval Applications (PMAs)
  • Product Development Protocols (PDPs)
  • Humanitarian Device Exemption (HDE)

Higher Cybersecurity Risk devices, include but are not limited to, implantable cardioverter defibrillators (ICDs), pacemakers, left ventricular assist devices (LVADs), brain stimulators and neurostimulators, dialysis devices, infusion and insulin pumps, and the supporting connected systems that interact with these devices such as home monitors and those with command and control functionality such as programmers.

Manufacturers should submit documentation demonstrating how these design expectations are met:

  • Prevent unauthorized use
  • Ensure trusted content by maintaining code, data, and
    execution Integrity
  • Maintain confidentiality of data
  • Design the device to detect cybersecurity events in a timely fashion
  • Design the device to respond to and contain the impact of a
    potential cybersecurity incident
  • Design the device to recover capabilities or services that
    were impaired due to a cybersecurity incident