Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) – Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases: Guidance for Stakeholders and Food and Drug Administration Staff

Issue Date: April 13, 2018
Issued by: Center for Devices and Radiological Health
Topic(s):
Status: Final

Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) – Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases: Guidance for Stakeholders and Food and Drug Administration Staff

The field of genomic testing is dynamic, building off of increasing amounts of data and a rapidly evolving technology base. While current regulatory approaches are appropriate for conventional diagnostics that measure a limited number of analytes associated with a disease or condition, the new sequencing technologies used in genomic testing can examine millions of DNA variants at a time, and thus warrant a flexible approach to oversight that is adapted to the novel and evolving nature of these tests. The Agency’s intent is to optimize its approach to regulatory oversight for Next Generation Sequencing (NGS) in vitro diagnostic (IVD) tests to support the needs of the rapidly evolving novel technologies in genomic medicine while at the same time meeting its critical mandate to ensure that medical devices have a reasonable assurance of safety and effectiveness.

Download the Guidance Document