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an SPDF is one approach to help ensure that the QS regulation is met. Because of its benefits in helping comply with the QS regulation and
cybersecurity, FDA encourages manufacturers to use an SPDF, but other approaches might also satisfy the QS regulation.
### B. Designing for Security
When reviewing premarket submissions, FDA intends to assess device cybersecurity based on a number of factors, including, but not limited to, the
device's ability to provide and implement the security objectives below throughout the device architecture. The security objectives below generally
may apply broadly to devices within the scope of this guidance, including, but not limited to, devices containing artificial intelligence (AI) and
cloud-based services.
Security Objectives:
• Authenticity, which includes integrity;
• Authorization:
• Availability:
• Confidentiality; and
• Secure and timely updatability and patchability.
Premarket submissions should include information that describes how the above security objectives are addressed by and integrated into the device
design. The extent to which security requirements, architecture, supply chain, and implementation are needed to meet these objectives will depend on
but may not be limited to:
- The device’s intended use, indications for use, and reasonably foreseeable misuse;
- The presence and functionality of its electronic data interfaces;
• Its intended and actual environment of use:
- The risks presented by cybersecurity vulnerabilities;
- The exploitability of the vulnerabilities; and
- The risk of patient harm due to vulnerability exploitation.
SPDF processes aim to reduce the number and severity of vulnerabilities and thereby reduce the exploitability of a medical device system and the
associated risk of patient harm. Because exploitation of known vulnerabilities or weak cybersecurity controls should be considered reasonably
foreseeable failure modes for medical device systems, these factors should be addressed in the device design. $ ^{19} $ One of the key benefits of
using an SPDF is that a medical device system is more likely to be secure by design, such that the device is designed from the outset to be secure
within its system and/or network of use throughout the device lifecycle.
### C. Transparency
A lack of cybersecurity information, such as information necessary to integrate the device into the use environment, as well as information needed
by users to maintain the medical device system’s cybersecurity over the device lifecycle, has the potential to affect the safety and effectiveness
of a device. In order to address these concerns, it is important for device users to
## Contains Nonbinding Recommendations
have access to information pertaining to the device’s cybersecurity controls, potential risks to the medical device system, and other relevant
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