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  1. Regulations
    All Titles
  2. title 21
    Food and Drugs
  3. chapter I-i7
    CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
  4. part 822
    PART 822—POSTMARKET SURVEILLANCE
  5. subpart G
    Subpart G—Records and Reports

Subpart G. Subpart G—Records and Reports

  • § 822.31 - What records am I required to keep?
  • § 822.32 - What records are the investigators in my surveillance plan required to keep?
  • § 822.33 - How long must we keep the records?
  • § 822.34 - What must I do with the records if the sponsor of the plan or an investigator in the plan changes?
  • § 822.35 - Can you inspect my manufacturing site or other sites involved in my postmarket surveillance plan?
  • § 822.36 - Can you inspect and copy the records related to my postmarket surveillance plan?
  • § 822.37 - Under what circumstances would you inspect records identifying subjects?
  • § 822.38 - What reports must I submit to you?
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