822.31 What records am I required to keep§ 822.31 What records am I required to keep?
You must keep copies of:
(a) All correspondence with your investigators or FDA, including required reports;
(b) Signed agreements from each of your investigators, if your surveillance plan uses investigators, stating the commitment to conduct the surveillance in accordance with the approved plan, any applicable FDA regulations, and any conditions of approval for your plan, such as reporting requirements;
(c) Your approved postmarket surveillance plan, with documentation of the date and reason for any deviation from the plan;
(d) All data collected and analyses conducted in support of your postmarket surveillance plan; and
(e) Any other records that we require to be maintained by regulation or by order, such as copies of signed consent documents, evidence of Institutional Review Board review and approval, etc.