What is the guidance about?
The guidance addresses general considerations for CGMP requirements for combination products and the purpose and content of specific CGMP provisions addressed in 21 CFR part 4. The guidance also contains hypothetical scenarios intended to clarify how to comply with certain CGMP requirements addressed in part 4 by presenting compliance considerations for specific types of combination products. Throughout the guidance, reference is made to other existing guidance and additional sources of information addressing CGMP requirements for drugs, devices, biological products, and human cells, tissues, and cellular and tissue-based products (HCT/Ps).
Significance of the guidance:
This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’s current thinking on CGMP requirements for combination products.
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