COMPLIANCE POLICY GUIDE (CPG)
CPG Sec. 280.100 - Stability Requirements - Licensed In Vitro Diagnostic Products July 2020
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.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.