Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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050
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Date of Entry 09/17/2018
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FR Recognition Number
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7-283
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Standard | |
CLSI POCT04 3rd Edition Essential Tools for Implementation and Management of a Point-of-Care Testing Program |
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Scope/AbstractMany potential sites are eligible for point-of-care testing (POCT). To achieve producing patient test results comparable with those from the medical laboratory, this guideline provides essential tools for implementing and managing POCT in both clinical and nonclinical settings. |
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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*
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. |