21 CFR Part 4 — Regulation of Combination Products
Subpart A — Current Good Manufacturing Practice Requirements for Combination Products
- § 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?
Subpart B — Postmarketing Safety Reporting for Combination Products
- § 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?