21 CFR Part 4
PART 4—REGULATION OF COMBINATION PRODUCTS
- PART 4—REGULATION OF COMBINATION PRODUCTS
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter A—General
- 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?
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