Title 21

PART 4 SUBPART B

Subpart B - Postmarketing Safety Reporting for Combination Products Source:81 FR 92624, Dec. 20, 2016, unless otherwise noted.

21:1.0.1.1.4.2.63.1SECTION 4.100
   4.100 What is the scope of this subpart
21:1.0.1.1.4.2.63.2SECTION 4.101
   4.101 How does the FDA define key terms and phrases in this subpart
21:1.0.1.1.4.2.63.3SECTION 4.102
   4.102 What reports must you submit to FDA for your combination product or constituent part
21:1.0.1.1.4.2.63.4SECTION 4.103
   4.103 What information must you share with other constituent part applicants for the combination product
21:1.0.1.1.4.2.63.5SECTION 4.104
   4.104 How and where must you submit postmarketing safety reports for your combination product or constituent part
21:1.0.1.1.4.2.63.6SECTION 4.105
   4.105 What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part