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
Information
Type
Guidance
Regulated products
Biologics, IVDMD, Medical Devices
Published
April 13, 2018
Last updated
March 2, 2020
Description
A guidance document for stakeholders and FDA staff on designing and validating NGS-based IVDs for diagnosing suspected germline diseases.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)