Part 4 — Regulation of Combination Products
Current through Sep 8, 2026
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360b-360f, 360h-360j, 360l, 360hh-360ss, 360aaa-360bbb, 360ddd, 360ddd-1, 371(a), 372-374, 379e, 381, 383, 394; 42 U.S.C. 216, 262, 263a, 264, 271.
Source: 78 FR 4321, Jan. 22, 2013, unless otherwise noted.
Sections
- § 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?