section_subject: "What records are the investigators in my surveillance plan required to keep?"
cfr_reference: "21 CFR 822.32"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
---
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.