21 CFR 820.200 - Servicing.
(a) Where servicing is a specified requirement, each manufacturer shall establish and maintain instructions and procedures for performing and verifying that the servicing meets the specified requirements.
(c) Each manufacturer who receives a service report that represents an event which must be reported to FDA under part 803 of this chapter shall automatically consider the report a complaint and shall process it in accordance with the requirements of § 820.198.
(1) The name of the device serviced;
(3) The date of service;
(4) The individual(s) servicing the device;
(5) The service performed; and
(6) The test and inspection data.