Standard: HHS - 21 CFR PART 4

REGULATION OF COMBINATION PRODUCTS

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Scope:

What is the scope of this subpart?

This subpart applies to combination products. It establishes which current good manufacturing practice requirements apply to these products. This subpart clarifies the application of current good manufacturing practice regulations to combination products, and provides a regulatory framework for designing and implementing the current good manufacturing practice operating system at facilities that manufacture co-packaged or single-entity combination products.

Organization: Food and Drug Administration (Medical Products Quality Assurance)
Document Number: 21 cfr part 4
Publish Date: 2015-04-01
Page Count: 3
Change Type: COMPLETE REVISION
Available Languages: EN
DOD Adopted: NO
ANSI Approved: NO
Most Recent Revision: YES
Current Version: YES
Status: Active

Document History

Document # Change Type Update Date Revision Status
21 CFR PART 4 Change Type: COMPLETE REVISION Update Date: 2016-04-01 Status: ACTV
21 CFR PART 4 Change Type: STCH Update Date: 2014-04-01 Status: INAC

Standards That Reference This Standard

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