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| Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices - Draft Guidance for Industry and Food and Drug Administration Staff | |||
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| 분류 | Molecular imaging, Guidance | 조회 | 2528 |
| 발행년도 | 2015 | 등록일 | 2015-10-02 |
| 출처 | FDA (바로가기) | ||
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FDA is issuing this guidance to provide industry and agency staff with recommendations regarding the technical performance assessment data that should be provided for regulatory evaluation of a digital whole slide imaging (WSI) system.
This document does not cover the clinical submission data that may be necessary to support approval or clearance.
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