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?