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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 047 Date of Entry 08/21/2017 
FR Recognition Number 13-92
Standard
ISO IEEE  11073-10421 First edition 2012-11-01
Health informatics - Personal health device communication - Part 10421: 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
Partial recognition. The following part(s) of the standard is (are) not recognized:
*Page 1, Section 1.1 Scope: The entire second paragraph.
*Page 3, Section 3.1 Definitions: The following definitions:
-Forced expiratory volume
-Peak expiratory flow rate
-Peak expiratory flow monitor
-Personal best peak expiratory flow
-Predicted average peak expiratory flow
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*
Guidance for Labeling Peak Flow Meters for Over the Counter Sale, Version 1.0, 1993 -
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM081354.pdf.

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 Contact
 Rachana Visaria
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  240-402-5628
  Rachana.Visaria@fda.hhs.gov
Standards Development Organizations
ISO International Organization for Standardization https://www.iso.org/
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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