21 CFR 820 - 820.200 servicing

Original text

Expert opinion

(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.

Servicing for medical devices is mostly found with equipment for healthcare instiutions, such as hospitals. Procedures must be implemented to define the servicing of a medical device and assure that the product meets the specification and requirements after successful service.

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

Service reports need to be collated and analyzed for track and trend, including statistical methodology as described in 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.

Not all feedback qualifies as a complaint. In the case of a reported service event reportable to the FDA under 21 CFR 803, a complaint is present. Such reports must be processed in accordance with 21 CFR 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.

Each service must be documented. The documentation must included at least the points given herein.

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