FDA certification of fiber optic devices used in telecommunications equipment

Customers frequently request that fiber optic devices used in telecommunications equipment be certified according to the Food and Drug Administration's Center for Devices and Radiological Health (FDA/CDRH) performance standard for laser products. This makes development of a formalized certification system by fiber optic device vendors an important means of satisfying these customers' requirements. By supplying a certified component, the fiber optic device vendor makes it easier for its customers to meet their own FDA/CDRH requirements as well as to respond to Underwriters' Laboratories and other listing agencies' questions about the certification of the fiber optic devices internal to their customer's equipment. Certification criteria for radiation emitting equipment are developed by the Food and Drug Administration's Center for Devices and Radiological Health (FDA/CDRH) under the authority of the Radiation Control for Health and Safety Act of 1968. To address FDA/CDRH and customer issues appropriately, it is desirable for the fiber optic device vendor to incorporate these requirements directly into its product development process. The product development process is often an integral part of the vendor's total quality management program that culminates in ISO 9000 certification. By using an existing quality system, the vendor can help to ensure compliance with the federal laser safety regulations and assure customer satisfaction on laser safety issues. This paper will describe the regulations, certification criteria, classification requirements and a quality process that contribute to ensuring correct and uniform certification of fiber optic devices.