SUBPART D—FDA Review and Action (§822.16 to §822.23) - Title 21 - Food and Drugs CFR - USA Laws Searching

CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 822—POSTMARKET SURVEILLANCE > SUBPART D—FDA Review and Action (§822.16 to §822.23)

SUBPART D—FDA Review and Action (§822.16 to §822.23)

822.16—What will you consider in the review of my submission?
822.17—How long will your review of my submission take?
822.18—How will I be notified of your decision?
822.19—What kinds of decisions may you make?
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
822.21—What must I do if I want to make changes to my postmarket surveillance plan after you have approved it?
822.22—What recourse do I have if I do not agree with your decision?
822.23—Is the information in my submission considered confidential?