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Part 4
FEDERAL · 21 CFR
Part 4 — Regulation of Combination Products
10 sections · Title 21: Food and Drugs
§ 4.1
What is the scope of this subpart?
§ 4.2
How does FDA define key terms and phrases in this subpart?
§ 4.3
What current good manufacturing practice requirements apply to my combination product?
§ 4.4
How can I comply with these current good manufacturing practice requirements for a co-packaged or single-entity combination product?
§ 4.100
What is the scope of this subpart?
§ 4.101
How does the FDA define key terms and phrases in this subpart?
§ 4.102
What reports must you submit to FDA for your combination product or constituent part?
§ 4.103
What information must you share with other constituent part applicants for the combination product?
§ 4.104
How and where must you submit postmarketing safety reports for your combination product or constituent part?
§ 4.105
What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part?