| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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054
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Date of Entry 07/06/2020
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FR Recognition Number
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13-114
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| Standard | |
IEEE Std 11073-10101-2019
Health informatics - Point-of-care medical device communication. Part 10101: Nomenclature |
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Scope/Abstract| This standard defines a nomenclature for communication of information from point-of-care medical devices. Primary emphasis is placed on acute care medical devices and patient vital signs information. The nomenclature also supports concepts in an object-oriented information model that is for medical device communication. |
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| Extent of Recognition
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Rationale for Recognition
This standard provides updated and new nomenclature elements which support semantic data exchange between medical devices and other entities, and therefore supports improved safety, effectiveness and secure interoperability.
This standard is relevant to all medical devices which claim interoperability with other networked entities and is being recognized on its scientific and technical merit because it supports existing regulatory policies. |
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Transition Period
| FDA recognition of IEEE Std 11073-10101-2019 [Rec# 13-114] will be superseded by recognition of IEEE Std 11073-10101b-2023 [Rec# 13-137]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 13-114] until July 04, 2027. After this transition period, declarations of conformity to [Rec# 13-114] will not be accepted. |
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Relevant FDA Guidance and/or Supportive Publications*
Relevant guidance:
1. Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2017.
2. Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 2005.
3. Off-The-Shelf Software Use in Medical Devices - Guidance for Industry and Food and Drug Administration Staff: issued September 2019
4. Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2019.
5. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff , issued October 2014
6. Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software, issued January 2005
7. Postmarket Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff , issued December 2016
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. |
