Guide on Using Standards for CBER Submissions

FDA has released a final guidance on “Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research.” The document provides CBER recommendations on the use of standards in product development and control as well as the use of such standards in CBER’s managed review process. It does not endorse any specific standards development organization or recommend specific standards for use in regulatory submissions.

“Sponsors’ wider use of existing relevant voluntary consensus standards can facilitate development by reducing the need to develop unique methods and/or reference materials for individual products,” the guidance says. “The use of standards can facilitate product development and reduce the amount of documentation needed in a regulatory submission, thus contributing to a more efficient submission evaluation and, ultimately, improving time to market.”