| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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032
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Date of Entry 08/06/2013
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FR Recognition Number
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13-55
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| Standard | |
IEEE Std 11073-10421-2010
Health informatics - Personal health device communication - Part 10421: Device specialization - Peak expiratory flow monitor (peak flow) |
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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. |
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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 11073-10421-2010 [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. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §868.1860 |
Meter, Peak Flow, Spirometry
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Class 2
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BZH
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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.
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.
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 Group (STG)
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| *These are provided as examples and others may be applicable. |
