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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 065 Date of Entry 12/22/2025 
FR Recognition Number 13-151
Standard
IEEE  Std 11073-10421-2023
Health Informatics-Device Interoperability - Part 10421: Personal Health Device Communication - Device Specialization - Peak expiratory flow monitor (peak flow)
Identical Adoption
ISO IEEE 11073-10421 Second Edition 2024-08
Health informatics - Device Interoperability - Part 10421: Personal health device communication - Device specialization - Peak expiratory flow monitor (peak flow)
Scope/Abstract
The scope of this standard is to establish a normative definition of communication between personal telehealth peak flow monitoring devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of functionality of a peak-flow monitoring device. The use case is restricted to personal respiratory monitoring and therefore does not include hospital-basedspirometry. Continuous and high-acuity monitoring (e.g., for emergency response) are outside the scope of the use case.In the context of personal health devices, a peak flow meter is a device is used to measure the respiratory function of those managing respiratory conditions such as asthma and chronic obstructive pulmonary disease. The ability to identify declining respiratory status prior to the need for acute intervention improves the quality of life for the individual while reducing the overall costs of care. Respiratory status data are collected by a personal respiratory monitoring device and forwarded to a central data repository for review and action by a health care provider. The data are episodic in nature and are forwarded at designated intervals or when the person is symptomatic.This standard provides the data modeling and its transport shim layer according to IEEE Std 11073-20601(TM)-2008 and does not specify the measurement method.
Extent of Recognition
Complete standard
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.
Transition Period
FDA recognition of IEEE Std 11073-10421-2010 [Rec# 13-55], and ISO IEEE 11073-10421 First edition 2012-11-01 [Rec# 13-92] will be superseded by recognition of IEEE Std 11073-10421-2023 [Rec# 13-151]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 13-55] and [Rec# 13-92] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 13-55] and [Rec# 13-92] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§868.1860 Meter, Peak Flow, Spirometry Class 2 BZH
Relevant FDA Guidance and/or Supportive Publications*
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.
FDA Technical Contacts
 Rachana Visaria
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  240-402-5628
  Rachana.Visaria@fda.hhs.gov
 Binoy Mathews
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  301-796-6475
  Binoy.Mathews@fda.hhs.gov
Standards Development Organization
IEEE Institute of Electrical and Electronic Engineers https://www.ieee.org/
FDA Specialty Task Group (STG)
Software/Informatics
*These are provided as examples and others may be applicable.
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