FDA-USE-OF-STANDARDS › Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases - Draft Guidance for Stakeholders and Food and Drug Administration Staff

FDA-USE-OF-STANDARDS - 2016 DRAFT - DRAFT
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Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases - Draft Guidance for Stakeholders and Food and Drug Administration Staff


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Document Number

16009

Revision Level

2016 DRAFT

Status

Draft

Publication Date

July 8, 2016

Page Count

29 pages