| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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064
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Date of Entry 05/26/2025
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FR Recognition Number
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13-147
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| Standard | |
IEEE Std 11073-10406-2023
Health informatics - Device Interoperability Part 10406: Personal health device communication - Device Specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
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Scope/Abstract| Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of the communication between personal basic electrocardiograph (ECG) devices and managers (e.g., cell phones, personal computers, personal health appliances, and set-top boxes) in a manner that enables plug-and-play interoperability is established in this standard. Appropriate portions of existing standards including ISO/IEEE 11073 terminology and IEEE 11073-20601 information models are leveraged. The use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability is specified. A common core of communication functionality for personal telehealth basic ECG (1- to 3-lead ECG) devices is defined. Monitoring ECG devices are distinguished from diagnostic ECG equipment with respect to including support for wearable ECG devices, limiting the number of leads supported by the equipment to three, and not requiring the capability of annotating or analyzing the detected electrical activity to determine known cardiac phenomena. This standard is consistent with the base framework and allows multifunction implementations by following multiple device specializations (e.g., ECG and respiration rate). |
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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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Transition Period
| FDA recognition of IEEE Std 11073-10406-2011 [Rec# 13-56] will be superseded by recognition of IEEE Std 11073-10406-2023 [Rec# 13-147]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 13-56] until July 4, 2027. After this transition period, declarations of conformity to [Rec# 13-56] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §870.2300 |
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
|
Class 2
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DRT
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| §870.2300 |
System, Network And Communication, Physiological Monitors
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Class 2
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MSX
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| §870.2300 |
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
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Class 2
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MWI
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| §870.2340 |
Electrocardiograph
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Class 2
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DPS
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| §870.2340 |
Monitor, St Segment
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Class 2
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MLC
|
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Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry: Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement), issued November 5, 1998.
Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2017.
Content of Premarket Submissions for Device Software Functions Guidance for Industry and Food and Drug Administration Staff, issued 2023.
Off-The-Shelf Software Use in Medical Devices - Guidance for Industry and Food and Drug Administration Staff: issued August 2023.
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.
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Guidance for Industry and Food and Drug Administration Staff , issued September 2023.
Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software, issued January 2005.
Postmarket Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff , issued December 2016.
Policy for Device Software Functions and Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff, issued September 2022.
General Principles of Software Validation Guidance for Industry and FDA Staff , issued January 2002.
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 Organization
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FDA Specialty Task Groups (STG)
| Software/Informatics (primary) |
| Cardiovascular |
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| *These are provided as examples and others may be applicable. |
