FDA Public Meeting on Adapting Regulatory Oversight of Next Generation Sequencing-Based Tests

On Friday September 23, 2016, the US Food and Drug Administration (FDA) convened a public meeting to gather feedback on two recently released draft guidance documents on Next Generation Sequencing tests:

    • “Use of Standards in the Food and Drug Administration's Regulatory Oversight of Next Generation Sequencing-Based In Vitro Diagnostics Used for Diagnosing Germline Diseases”
    • “Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing-Based In Vitro Diagnostics.”

ACMG’s Medical Director, David Flannery, MD, FACMG, presented a prepared statement on behalf of ACMG.

Prepared Statement of Dr. Flannery