Food and Drug Administration Releases Final Guidance on Next-Generation Sequencing

Apr 20, 2018

The Food and Drug Administration (FDA) recently finalized two guidance documents on next-generation sequencing (NGS). The goal of both documents is to aid and expedite developers in bringing their product to market.

The finalized guidance provides recommendations on creating and developing accurate tests, as well as using genetic variant databases to support the trials. Director Jeffrey Shuren, Director of FDA Center for Devices and Radiological Health explained, “The rapid adoption of NGS technologies in research and clinical settings is helping to identify countless new genetic variants. However, information about genetic variants is generally stored in a manner that is not publicly accessible…[the] release of the FDA’s final guidance on genetic variant databases will help change this paradigm by encouraging data sharing and the accumulation in public databases of evidence supporting the clinical validity of genomic tests to help provide an event more efficient path the market.”

One of the documents provides insight into what the agency is looking for in a successful premarket submission, including how validity of tests and trials was determined. The other document details how product developers can better use current resources, including FDA databases, to support the clinical validation of the tests and products they are developing.  FDA will be holding a webinar on these two final guidance documents on May 24, 2018.

For more information on the May 24 webinar, click here: https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm603766.htm  

To view the final guidance documents, click here: 
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM509837.pdf

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM509838.pdf

You are now leaving ASME.org