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Sec. 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.

    (b) Each manufacturer shall analyze service reports with appropriate statistical methodology in accordance with Sec. 820.100.

    (c) Each manufacturer who receives a service report that represents an event which must be reported to FDA under part 803 or 804 of this chapter shall automatically consider the report a complaint and shall process it in accordance with the requirements of Sec. 820.198.

    (d) Service reports shall be documented and shall include:

    (1) The name of the device serviced;

    (2) Any device identification(s) and control number(s) used;

    (3) The date of service;

    (4) The individual(s) servicing the device;

    (5) The service performed; and

    (6) The test and inspection data.

For correct application of this information, see NOTE on Contents page