FDA Unveils In Vitro Guidance
The U.S. Food and Drug Administration has issued new guidance to help manufacturers in the creation of in vitro diagnostic (IVD) device studies.
The guidance document, which is written in a question and answer format, is intended to assist manufacturers in the development of IVD studies, particularly those exempt from most of the requirements of the Investigative Device Exemptions (IDE) regulations.
“The document is intended to facilitate the movement of new IVD technology from the investigational stage to the marketing stage,” the document reads.
The material answers questions about what regulations contain provisions on IVD, and how to determine the applicability of IDE regulations to an IVD study.
For more information, click here (PDF).