Title 21
PART 822 SUBPART D
Subpart D - FDA Review and Action
- 21 U.S.C. 331, 352, 360i, 360l, 371, 374.
- 67 FR 38887, June 6, 2002, unless otherwise noted.
| 21:8.0.1.1.14.4.1.1 | SECTION 822.16 | 822.16 What will you consider in the review of my submission | |
| 21:8.0.1.1.14.4.1.2 | SECTION 822.17 | 822.17 How long will your review of my submission take | |
| 21:8.0.1.1.14.4.1.3 | SECTION 822.18 | 822.18 How will I be notified of your decision | |
| 21:8.0.1.1.14.4.1.4 | SECTION 822.19 | 822.19 What kinds of decisions may you make | |
| 21:8.0.1.1.14.4.1.5 | SECTION 822.20 | 822.20 What are the consequences if I fail to submit a postmarket surveillance plan, my plan is disapproved and I fail to submit a new plan, or I fail to conduct surveillance in accordance with my approved plan | |
| 21:8.0.1.1.14.4.1.6 | SECTION 822.21 | 822.21 What must I do if I want to make changes to my postmarket surveillance plan after you have approved it | |
| 21:8.0.1.1.14.4.1.7 | SECTION 822.22 | 822.22 What recourse do I have if I do not agree with your decision | |
| 21:8.0.1.1.14.4.1.8 | SECTION 822.23 | 822.23 Is the information in my submission considered confidential |