Current Good Manufacturing Practice Requirements for Combination Products

Guidance for Industry and FDA Staff

- 555KB

The draft of this document was issued in January 2015.

Additional copies are available from:
Office of Combination Products
Food and Drug Administration
WO32, Hub/Mail Room #5129
10903 New Hampshire Avenue
Silver Spring, MD 20993
(Tel) 301-796-8930
(Fax) 301-847-8619
http://www.fda.gov/CombinationProducts/

For questions regarding this document, contact the office of Combination Products at 301- 796-8930 or combination@fda.gov.

U.S. Department of Health and Human Services
Food and Drug Administration
Office of Combination Products (OCP) in the Office of the Commissioner
Center for Biologics Evaluation and Research (CBER)
Center for Drug Evaluation and Research (CDER)
Center for Devices and Radiological Health (CDRH)
Office of Regulatory Affairs (ORA)

January 2017

This guidance describes and explains the final rule on CGMP requirements for combination products (final rule as codified in 21 CFR part 4) that FDA issued on January 22, 2013. 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 was intended to provide such clarification and specify how compliance with applicable CGMP requirements may be demonstrated.