1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 822 - POSTMARKET SURVEILLANCE
  6. Subpart C - Postmarket Surveillance Plan
  7. 21 CFR § 822.14
21 CFR § 822.14
May I reference information previously submitted instead of submitting it again?
June 25, 2020
CFR

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.

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§ 822.13 [Reserved]
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§ 822.15 How long must I conduct postmarket surveillance of my device?

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