| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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061
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Date of Entry 10/09/2023
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FR Recognition Number
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13-130
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| Standard | |
ANSI AAMI 2700-2-1:2022
Medical devices and medical systems - Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging |
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Scope/AbstractThis document provides general functional, performance, security, and interoperability requirements of ICE data logging systems including the recording and storage of data in support of forensic analysis of ICE systems. DATA LOGs, data logging, and data loggers can play an important role in maintaining and improving the basic safety and essential performance of INTEGRATED CLINICAL ENVIRONMENTs by enabling the forensic assessment of the ICE system and its components.
NOTE 1: In other industries, this type of data logger is referred to as a "black box recorder."
NOTE 2: The ICE data logger is not required to be capable of real-time clinical/patient monitoring.
NOTE 3: The ICE data logger is intended to provide a data store that can be used to assist in confirming that the ICE system and its components were operating as intended.
Clinical patient management is outside the scope of this standard.
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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.
Note: A declaration of conformity to this standard may not fulfill all requirements under Section 524B of the Federal Food, Drug, and Cosmetic Act (21 USC §360n-2: Ensuring cybersecurity of devices) [as amended by Section 3305 of the Consolidated Appropriations Act, 2023]. This standard doesn't necessarily meet the needs of local, state, and federal law enforcement for cybersecurity related forensic evidence capture. |
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Public Law, CFR Citation(s) and Procode(s)*
| 21 USC 360n-2: Ensuring cybersecurity of devices |
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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. NIST SP 800-86 Guide to Integrating Forensic Techniques into Incident Response, issued August 2006.
9. Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology - Guidance for Industry and Food and Drug Administration Staff, issued September 2023.
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 Contacts
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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. |
