| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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056
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Date of Entry 06/07/2021
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FR Recognition Number
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13-118
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| Standard | |
IEEE Std 11073-40102:2020
Health informatics - Device interoperability. Part 40102: Foundational - Cybersecurity - Capabilities for mitigation. |
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Scope/AbstractWithin the context of secure plug-and-play interoperability, cybersecurity is the process and capability of preventing unauthorized access or modification, misuse, denial of use, or the unauthorized use of information that is stored on, accessed from, or transferred to and from a PHD/PoCD. The capability part of cybersecurity is information security controls related to both digital data and the relationships to safety and usability.
For PHDs/PoCDs, this standard defines a security baseline of application layer cybersecurity mitigation techniques for certain use cases or for times when certain criteria are met. This standard provides a scalable information security toolbox appropriate for PHD/PoCD interfaces, which fulfills the intersection of requirements and recommendations from National Institute of Standards and Technology (NIST) and the European Network and Information Security Agency (ENISA). This standard maps to the NIST cybersecurity framework [B15]; IEC TR 80001-2-2 [B8]; and the Spoofing, Tampering, Repudiation, Information Disclosure, Denial of Service, and Elevation of Privilege (STRIDE) classification scheme. The mitigation techniques are based on the extended CIA triad (Clause 4) and are described generally to allow manufacturers to determine the most appropriate algorithms and implementations.
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| Extent of Recognition
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Rationale for Recognition
This standard is relevant to all medical devices which claim interoperability with other networked entities and is being recognized on its scientific and technical merit because it supports existing regulatory policies.
NOTE: Conformance to this standard may not satisfy all the cybersecurity requirements outlined in Section 524B of FD&C Act or the recommendations in the (1) listed below (Relevant FDA Guidance). Manufacturers should consider the information contained within these resources in their assessment of cybersecurity for their device. |
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Relevant FDA Guidance and/or Supportive Publications*
1. Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, Guidance for Industry and Food and Drug Administration Staff, issued June 2025.
2. Postmarket Management of Cybersecurity in Medical Devices, Guidance for Industry and Food and Drug Administration Staff, issued December 2016.
3. Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices, Guidance for Industry and Food and Drug Administration Staff, issued September 2017.
4. Content of Premarket Submissions for Device Software Functions, Guidance for Industry and Food and Drug Administration Staff, issued June 2023.
5. Off-The-Shelf Software Use in Medical Devices, Guidance for Industry and Food and Drug Administration Staff, issued August 2023.
6. Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices, Guidance for Industry and Food and Drug Administration Staff, issued September 2022.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contact
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
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