Sisk J E
Med Prog Technol. 1982;9(2-3):181-6.
This paper focuses on two major areas of US federal policy that relate to medical devices, regulations regarding premarketing approval and arrangements for financing the use of devices. Other relevant areas, such as patents, liability, and taxation, are discussed more briefly. In 1976 legislation authorized the federal Food and Drug Administration (FDA) to require manufacturers of medical devices to show that their products meet acceptable levels of safety and effectiveness. FDA has classified each device into one of three classes according to the extent of regulation needed to ensure safety and effectiveness. Although all devices must conform to general manufacturing controls and some to premarketing approval, no performance standards have yet been developed. About two-thirds of all expenditures for medical care in the United States are paid by private or public insurers. Although procedures vary for institutional and individual providers, payment is usually made after the medical care has been provided and covers the provider's costs or charges. Prevailing insurance coverage and payment methods contain incentives for the innovation and use of medical devices that are part of mainstream medical care. At the same time, these financial arrangements discourage preventive and rehabilitative devices, which are generally excluded from insurance coverage.
本文聚焦于美国联邦政策中与医疗设备相关的两个主要领域，即上市前批准的法规以及设备使用的融资安排。其他相关领域，如专利、责任和税收等，将进行更简要的讨论。1976年的立法授权联邦食品药品监督管理局（FDA）要求医疗设备制造商证明其产品符合可接受的安全和有效性标准。FDA根据确保安全和有效性所需的监管程度，将每种设备分为三类之一。尽管所有设备都必须符合一般生产控制要求，有些还需获得上市前批准，但尚未制定性能标准。在美国，约三分之二的医疗保健支出由私人或公共保险公司支付。尽管机构和个体提供者的支付程序各不相同，但通常在提供医疗服务后进行支付，涵盖提供者的成本或费用。现行的保险覆盖范围和支付方式对作为主流医疗保健一部分的医疗设备的创新和使用具有激励作用。与此同时，这些财务安排不利于预防性和康复性设备，这些设备通常被排除在保险覆盖范围之外。
