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首页> 外文期刊>Journal of prosthetics and orthotics: JPO >FDA Regulation of Cranial Remodeling Devices
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FDA Regulation of Cranial Remodeling Devices

机译：FDA颅骨重塑装置法规

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Regulation of cranial remodeling began in 1995 with an insurance provider who did not want to provide coverage for treatment. The provider denied coverage for the DOC Band (Cranial Technologies, Inc., Phoenix, AZ) by claiming the device was considered experimental/investiga-tional because it had not been approved by the U.S. Food and Drug Administration (FDA). After numerous conversations, during which it was explained these devices were custom-made and therefore exempt from regulation, the insurance company contacted the FDA to register a complaint. As required by law, an inspector from the regional office of the FDA did an unannounced inspection of the facility and determined that the matter had to be referred to the Office of Device Evaluation (ODE) for clarification. After careful consideration, the ODE responded that these devices did not meet the criteria for a "custom device" and stated that although each device was clearly "customized" to fit the patient, it was not a custom device as defined by Act 21 CFR 812.3 (S. Grumpier, personal communication, 1996). Approval from the FDA was required.
机译：颅骨重塑的监管始于1995年，当时一家保险公司不想提供治疗的保险。提供商声称该设备被美国食品药品监督管理局（FDA）批准，被认为是实验性/研究性的，因此拒绝了DOC频段的覆盖（Cranial Technologies，Inc.，亚利桑那州凤凰城）。经过无数次交谈，在解释过程中，这些设备是定制的，因此不受监管，保险公司联系FDA进行投诉。根据法律要求，FDA区域办事处的检查人员对设施进行了未经事先通知的检查，并确定此事必须移交给设备评估办公室（ODE）进行澄清。在仔细考虑之后，ODE回答说这些设备不符合“定制设备”的标准，并指出，尽管每个设备都明确地“定制”以适合患者，但它不是Act 21 CFR 812.3所定义的定制设备。 （S. Grumpier，个人通讯，1996年）。需要获得FDA的批准。

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