This guidance describes and explains the final rule on current good manufacturing practice (CGMP) requirements for combination products that FDA issued on January 22, 2013 (final rule). (21 Code of Federal Regulations (CFR) part 4). Prior to issuance of the final rule, although CGMP regulations were in place to establish requirements for drugs, devices, biological products, and Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), there were no regulations to clarify and explain the application of these CGMP requirements to combination products. The final rule did not establish any new requirements; it was intended to clarify which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products, and to set forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with applicable CGMP requirements.
Section II of this document provides the definition of “combination product,” an overview of the final rule, and describes the role of the lead center and other Agency components4 with respect to combination product CGMP issues. Section III addresses certain general considerations for CGMP compliance for combination products. Section IV presents the purpose and content of specific CGMP requirements addressed in the final rule. Finally, Section V analyzes hypothetical scenarios that illustrate how to comply with certain CGMP requirements for specific types of combination products. Throughout this guidance, the Agency also refers to existing guidance and additional resources that address CGMP requirements for drugs, devices, biological products, and HCT/Ps, to further inform combination product manufacturers on how to comply with CGMP requirements.