Issue Date: July 31, 2020
Issued by: Center for Biologics Evaluation and Research
Topic(s): Investigation & Enforcement,
Status: Final
CPG Sec. 280.100 – Stability Requirements – Licensed In Vitro Diagnostic Products
The purpose of this Compliance Policy Guide (CPG) is to provide guidance to FDA staff on stability studies for in vitro diagnostic products (IVDs) licensed by the Center for Biologics Evaluation and Research (CBER). In general, FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the FDA’s current thinking on a topic and should be viewed only as recommendations unless specific regulatory or statutory requirements are cited. The use of the word “should” in FDA’s guidances means that something is suggested or recommended but not required.
Download the Guidance Document
