Maps to
21 CFR Part 822: §822.31 What records am I required to keep?, §822.33 How long must we keep the records?, §822.35 Can you inspect my manufacturing site or other sites involved in my postmarket surveillance plan?, §822.36 Can you inspect and copy the records related to my postmarket surveillance plan?, §822.38 What reports must I submit to you?
Requirement text
Manufacturers subject to a postmarket surveillance order must maintain specified records and submit interim and final reports as required by the approved plan. Records must include copies of all correspondence with investigators or FDA (including required reports), signed agreements from each investigator if the surveillance plan uses investigators, the approved plan with documentation of the date and reason for any deviation, all data collected and analyses conducted in support of the plan, and any other records FDA requires to be maintained by regulation or by order. The manufacturer, the designated person, and the manufacturer's investigators must keep all records for 2 years after FDA has accepted the final report, unless FDA specifies otherwise. FDA can review the manufacturer's postmarket surveillance programs during regularly scheduled inspections, inspections initiated to investigate recalls or other similar actions, and inspections initiated specifically to review the postmarket surveillance plan, and may also inspect any other person or site involved in the surveillance, such as investigators or contractors; FDA may, at a reasonable time and in a reasonable manner, inspect and copy any records pertaining to the conduct of postmarket surveillance that are required to be kept by Part 822, and the records and information required by Part 822 must be produced within 72 hours of the initiation of the inspection.