Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter H - Medical Devices |
Part 822 - Postmarket Surveillance |
Subpart D - FDA Review and Action |
§ 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? |
§ 822.21 - 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? |