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 g - RECORDS AND REPORTS

822.32 - What records are the investigators in my surveillance plan required to keep?

Your investigator must keep copies of: (a) All correspondence between investigators, FDA, the manufacturer, and the designated person, including required reports.

  (b) The approved postmarket surveillance plan, with documentation of the date and reason for any deviation from the plan.

  (c) All data collected and analyses conducted at that site for postmarket surveillance.

  (d) Any other records that we require to be maintained by regulation or by order.