| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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051
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Date of Entry 01/14/2019
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FR Recognition Number
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13-106
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| Standard | |
IEEE Std 11073-10207-2017
Health informatics - Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication |
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Scope/Abstract| The scope of this standard is the definition and structuring of information that is communicated in a distributed system of point-of-care medical devices and medical information technology (IT) systems in which medical data needs to be exchanged or networked point-of-care medical devices need to be controlled. The standard provides a Participant Model and Communication Model derived from the IEEE 11073 Domain Information Model (IEEE 11073-10201 DIM). Furthermore, it utilizes the IEEE 11073 Nomenclature (IEEE 11073-10101) and supports other coding systems to convey the semantics of any information elements. The definition of network transport mechanisms is outside the scope of this standard. |
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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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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.
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. |
