Subpart B—Postmarketing Safety Reporting for Combination Products

1. CFR
2. ›
3. Title 21
4. ›
5. Chapter I
6. ›
7. Part 4
8. ›
9. 21 CFR Part 4 Subpart B

Sections

• 4.100
  § 4.100 What is the scope of this subpart?
• 4.101
  § 4.101 How does the FDA define key terms and phrases in this subpart?
• 4.102
  § 4.102 What reports must you submit to FDA for your combination product or constituent part?
• 4.103
  § 4.103 What information must you share with other constituent part applicants for the combination product?
• 4.104
  § 4.104 How and where must you submit postmarketing safety reports for your combination product or constituent part?
• 4.105
  § 4.105 What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part?