top of page

USFDA MD Guidance: Cybersecurity-Quality System Considerations & Content of Premarket Submissions

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released a final guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" this Wednesday (27 September 2023).

In today's interconnected world, technology plays a vital role in healthcare, improving patient outcomes, and enhancing the efficiency of medical treatments. However, as medical devices become increasingly connected and reliant on digital systems, cybersecurity has emerged as a critical concern.

As part of its premarket submissions for devices with cybersecurity risks, FDA provides recommendations to industry on cybersecurity device design, labeling, and documentation.

The guidance document applies to devices with cybersecurity considerations, including but not limited to devices with software functions or that contain software (including firmware) or programmable logic, and includes devices with network capabilities and other connected capabilities as well.

As part of this guidance, the Center for Devices and Radiological Health (CDRH) or the Center for Biologics Evaluation and Research (CBER) provides recommendations regarding the cybersecurity information that should be submitted for devices under the following premarket submission types:

  • Premarket Notification (510(k)) submissions

  • De Novo requests

  • Premarket Approval Applications (PMAs) and PMA supplements

  • Product Development Protocols (PDPs)

  • Investigational Device Exemption (IDE) submissions

  • Humanitarian Device Exemption (HDE) submissions

  • Biologics License Application (BLA) submissions; and

  • Investigational New Drug (IND) submissions.

This guidance provides essential guidance to improve the safety and effectiveness of devices and, when followed, will have a positive impact on their safety and effectiveness. Among the cybersecurity considerations covered in this guidance are software, hardware, and firmware, which all may have an impact on device safety and effectiveness.

To know more about the principles, cybersecurity risks, authentication etc., click this LINK.


bottom of page