Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests - Guidance for Industry and FDA Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Biostatistics
Published
March 12, 2007
Last updated
March 19, 2020
Description
Statistical guidance for reporting results from diagnostic test studies, aimed at industry and FDA staff. Covers biostatistics.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)