Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases[PDF 707 KB]

Public Health Genomics Knowledge Base (v1.2)

• Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases[PDF 707 KB] 
  Draft Guidance for Stakeholders and Food and Drug Administration Staff, FDA, July 8, 2016