GroundRules
21 CFR 822.32: What records are the investigators in my surveillance plan required to keep?
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 G—Records and Reports
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.
Collected 2026-08-27T02:24:47Z. Source file · JSON