Title 21
PART 4 SUBPART B
Subpart B - Postmarketing Safety Reporting for Combination Products
- 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360b-360f, 360h-360j, 360l, 360hh-360ss, 360aaa-360bbb, 371(a), 372-374, 379e, 381, 383, 394; 42 U.S.C. 216, 262, 263a, 264, 271.
- Source: 78 FR 4321, Jan. 22, 2013, unless otherwise noted.
21:1.0.1.1.4.2.63.1 | SECTION 4.100 | 4.100 What is the scope of this subpart | |
21:1.0.1.1.4.2.63.2 | SECTION 4.101 | 4.101 How does the FDA define key terms and phrases in this subpart | |
21:1.0.1.1.4.2.63.3 | SECTION 4.102 | 4.102 What reports must you submit to FDA for your combination product or constituent part | |
21:1.0.1.1.4.2.63.4 | SECTION 4.103 | 4.103 What information must you share with other constituent part applicants for the combination product | |
21:1.0.1.1.4.2.63.5 | SECTION 4.104 | 4.104 How and where must you submit postmarketing safety reports for your combination product or constituent part | |
21:1.0.1.1.4.2.63.6 | SECTION 4.105 | 4.105 What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part |