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.
|21:126.96.36.199.188.8.131.52||SECTION 822.16||822.16 What will you consider in the review of my submission|
|21:184.108.40.206.220.127.116.11||SECTION 822.17||822.17 How long will your review of my submission take|
|21:18.104.22.168.22.214.171.124||SECTION 822.18||822.18 How will I be notified of your decision|
|21:126.96.36.199.188.8.131.52||SECTION 822.19||822.19 What kinds of decisions may you make|
|21:184.108.40.206.220.127.116.11||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|
|21:18.104.22.168.22.214.171.124||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|
|21:126.96.36.199.188.8.131.52||SECTION 822.22||822.22 What recourse do I have if I do not agree with your decision|
|21:184.108.40.206.220.127.116.11||SECTION 822.23||822.23 Is the information in my submission considered confidential|