Gastroenterology-Urology Devices; Denial of Request for Change in Classification of Fiber Optic Light Sources

摘要

The Food and Drug Administration (FDA) is denying the petition submitted by QED, Inc. (QED) to reclassify fiber optic light sources used as accessories to endoscopes from class II to class I. The agency is denying the petition because QED failed to provide any new information to establish that general controls would provide reasonable assurance of the safety and effectiveness of the device. This notice also summarizes the basis for the agency's decision. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the FDA Modernization Act of 1997 (the FDAMA).