21 CFR Subpart A
Current Good Manufacturing Practice Requirements for Combination Products
June 25, 2020
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4.1
What is the scope of this subpart?
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4.2
How does FDA define key terms and phrases in this subpart?
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4.3
What current good manufacturing practice requirements apply to my combination product?
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4.4
How can I comply with these current good manufacturing practice requirements for a co-packaged or single-entity combination product?