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U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 28, 2025
All Titles
Title 21
Chapter I
Part 4
Subpart B - 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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