---
kind: "section"
citation: "21 C.F.R. § 822.32"
title: "21"
number: "822.32"
heading: "What records are the investigators in my surveillance plan required to keep?"
url: "https://uscodex.org/cfr/21/822.32"
---

# §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.**

## Notes

### Authority

Authority: 21 U.S.C. 331, 352, 360i, 360l, 371, 374.

### Source

Source: 67 FR 38887, June 6, 2002, unless otherwise noted.