(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.

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

(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.

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

(1) The name of the device serviced;

(2) Any unique device identifier (UDI) or universal product code (UPC), and any other 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.

[61 FR 52654, Oct. 7, 1996, as amended at 69 FR 11313, Mar. 10, 2004; 78 FR 58822, Sept. 24, 2013]