Compliance Policy Guides (CPGs) explain Food and Drug Administration (FDA) policy on regulatory issues related to FDA laws or regulations. They advise FDA’s field inspection and compliance staffs, as well as the industry, as to the Agency's strategy and policies to be applied when determining industry compliance.
The field staff is continually encouraged to contact the Office of Strategic Planning and Operational Policy (OSPOP)/Division of Operational Policy (DOP), within the Office of Regulatory Affairs (ORA) when they need clarification on an existing CPG or see a need for a new guidance.
Please send comments or suggestions for improvement to ORAPolicyStaffs@fda.hhs.gov
Please refer to SMG 7100.1: FDA Staff Manual Guides, Volume IV - Agency Program Directives for more information.