21 CFR § 822.32
What records are the investigators in my surveillance plan required to keep?
June 25, 2020
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.
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