Regulatory Information

Current Good Manufacturing Practice Requirements for Combination Products

Draft Guidance for Industry and FDA Staff

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This guidance document is being distributed for comment purposes only.

Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

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 John Barlow Weiner, Associate Director for Policy, Office of Combination Products, at 301-796-8930 or john.weiner@fda.hhs.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 2015

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. 

Page Last Updated: 01/28/2015
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