Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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059
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Date of Entry 12/19/2022
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FR Recognition Number
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13-128
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Standard | |
IEEE UL Std 2621.2-2022 Standard for Wireless Diabetes Device Security: Information Security Requirements for Connected Diabetes Solutions |
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Scope/AbstractThis standard describes the security functional requirements (SFRs), which compose a protection profile (PP), for connected diabetes devices (CDDs). The scope of the PP within the development and evaluation process is described in ISO/IEC 15408.1 In particular, a PP defines the IT security requirements of a generic type of Target of Evaluation (TOE) and specifies the security measures to be offered by that TOE to meet stated requirements. |
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Extent of Recognition
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Relevant FDA Guidance and/or Supportive Publications*
1. Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2017.
2. Content of Premarket Submissions for Device Software Functions - Guidance for Industry and Food and Drug Administration Staff, issued June 2023.
3. Off-The-Shelf Software Use in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued August 2023.
4. Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2019.
5. Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Guidance for Industry and Food and Drug Administration Staff, issued September 2023.
6. Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software, issued January 2005.
7. Postmarket Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued December 2016.
8. IEC/ISO 80001-5-1:2022 - Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle.
9. ANSI/NEMA HN 1-2019 - American National Standard - Manufacturer Disclosure Statement for Medical Device Security.
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 Organizations
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |