Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research Guidance for Industry March 2019

GUIDANCE DOCUMENT

• Docket Number: FDA-2017-D-6535
• Issued by: Center for Biologics Evaluation and Research

The purpose of this guidance is to describe the recommendations of the Center for Biologics Evaluation and Research (CBER) on the use of standards in product development and control as well as the use of such standards in CBER’s managed review process. CBER recognizes the value of standards and encourages the use of appropriate standards in the development and control of CBER-regulated medical products. Sponsors’ use of standards can facilitate product development and provide a more efficient evaluation of regulatory submissions, including investigational new drug applications (INDs), biologics license applications (BLAs), new drug applications (NDAs), investigational device exemptions (IDEs), premarket approval applications, and premarket notifications, supplements, and amendments. This guidance does not endorse the activities of specific Standards Development Organizations (SDOs) or recommend specific standards for use in regulatory submissions. This guidance finalizes the draft guidance of the same title dated December 2017.

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