---

      

Meeting Materials

• Presentation
• Printable Slides
• Transcript

On July 27, the FDA hosted two webinars about draft guidances released July 6, which propose methods to streamline oversight of Next Generation Sequencing (NGS)-based tests:

• "Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases”
• “Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics”

These two draft guidances are part of the FDA’s participation in President Obama’s Precision Medicine Initiative (PMI), which aims to take advantage of the progress made in genomic testing to accelerate the development of new treatments that take into account individual differences in people’s genes, environments, and lifestyles.

12:00 – 1:00 p.m. ET: “Next Generation Sequencing Draft Guidances: Technical and Regulatory Aspects,” will focus on the technical and regulatory aspects of the guidances.

1:30 – 2:30 p.m. ET: “Next Generation Sequencing Draft Guidances: Implications for Patients and Providers,” will address the significance of these guidances for patients and health care professionals.

If you have general questions about these guidances, please contact CDRH’s Division of Industry and Consumer Education (DICE) at [email protected], 1-800-638-2041, or 301-796-7100.

Food and Drug Administration
Center for Devices and Radiological Health