| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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065
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Date of Entry 12/22/2025
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|
FR Recognition Number
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13-154
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| Standard | |
IEEE Std 11073-10429-2022
Health informatics - Device Interoperability - Part 10429: Personal Health Device Communication - Device Specialization - Spirometry |
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Scope/Abstract| Within the context of the ISO/IEEE 11073 family of standards for device communication, in this standard, a normative definition of the communication between personal telehealth spirometry devices and managers (e.g., cell phones, personal computers, personal health appliances, set-top boxes) is established in a manner that enables plug-and-play interoperability. Appropriate portions of existing standards are leveraged, including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. The use of specific term codes, formats, and behaviors are specified in telehealth environments restricting optionality in base frameworks in favor of interoperability. A common core of communication functionality for personal telehealth spirometry is defined in this standard. |
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| Extent of Recognition
|
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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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.
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.
Policy for Device Software Functions and Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff, issued September 2022.
Multiple Function Device Products: Policy and Considerations - Guidance for Industry and Food and Drug Administration, issued July 2020.
Content of Premarket Submissions for Device Software Functions - Guidance for Industry and Food and Drug Administration Staff, issued 2023.
Postmarket Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued December 2016.
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Guidance for Industry and Food and Drug Administration Staff, issued September 2023.
Clinical Decision Support Software - 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. |
