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국내·외 동반진단의료기기 관련 가이드라인
| 연도 | 제목 |
| 2014 | In Vitro Companion Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff(美, FDA Guidance) |
| 2015 | 체외동반진단기기(In vitro Companion Diagnostics Devices) 허가·심사 가이드라인 |
| 2016 | Principles for Codevelopment of an In vitro Companion Diagnostic Device with a Therapeutic Product(美, FDA Draft-Guidance) |
| 2018 | 액상생검(Liquid Biopsy)을 이용한 동반진단의료기기의 안전성·성능 및 임상시험계획서 평가 가이드라인 |
| 2018 | 동반진단의료기기를 사용하는 의약품의 허가사항 기재 가이드라인 |
| 2020 | Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products(美, FDA Guidance) |
CLSI 가이드라인
| 연도 | 제목 |
| EP6-A | Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline |
| EP17-A2 | Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline-Second Edition |
| EP25-A | Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline |
| H3-H6 | Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture |
| H21-A5 | Collection, Transport, and Processing of blood specimens for testing plasma-based coagulation assay and molecular hemostasis assay |
| GP44-A4 | Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests, 4th Edition |
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