GroundRules
21 CFR 822.14: May I reference information previously submitted instead of submitting it again?
Where this section sits in the code
- 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 C—Postmarket Surveillance Plan
Yes, you may reference information that you have submitted in premarket submissions as well as other postmarket surveillance submissions. You must specify the information to be incorporated and the document number and pages where the information is located.
Collected 2026-08-27T02:24:47Z. Source file · JSON