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FDA发布的主要行业指南
撰稿：lilielie更新日期：2019-01-21
FDA颁布的技术指南（guideline）用以向生产商、消费者及监管人员解释说明法规条款、业务流程，传达FDA当前工作的重点。虽然这些指导文件并不具备强制执行的法律效应，但由于它们经过了严格和长时间的讨论和论证，具有较强的科学性，因此实际操作中企业一般可以参考这些文件进行。技术指南是FDA监管体系（公共法令、部门法规、技术指南）中的第三层依据。三个层级之间互相协同、补充，构成了FDA监管的法律基础。
目前与体外诊断有关的重要技术指南有：
| 名称 | 发布时间 | 文件状态 |
| Pharmacogenomic Data Submissions | 2005 | final guidance |
| Pharmacogenomic Tests and Genetic Tests for Heritable Markers | 2007 | final guidance |
| In Vitro Diagnostic Multivariate Index Assays | 2007 | draft guidance |
| E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data, and Sample Coding Categories | 2008 | final guidance |
| E16 Guidance on Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualifications Submissions | 2011 | final guidance |
| Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products | 2012 | draft guidance |
| Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling | 2013 | final guidance |
| Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling | 2013 | final guidance |
| Qualification Process for Drug Development Tools | 2014 | final guidance |
| In Vitro Companion Diagnostic Devices | 2014 | final guidance |
| Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) | 2014 | draft guidance |
| FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs) | 2014 | draft guidance |
| Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases | 2016 | draft guidance |
| Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics | 2016 | draft guidance |
| Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product | 2016 | draft guidance |
| Discussion Paper on Laboratory Developed Tests (LDTs) | 2017 | in discussion |
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