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