What is amedical device?

什么是医疗器械？

A medicaldevice is "an instrument, apparatus, implement, machine,contrivance, implant, in vitro reagent, or other similar or related article,including a component part, or accessory which is:

医疗器械是“一种工具，仪器，器械，机器，设备，植入物，体外试剂，或其他类似或相关的物品，包括组件部分或附件：

·        recognized in the official National Formulary, or the UnitedStates Pharmacopoeia, or any supplement to them,

·        官方国家处方认可或美国药典或其任何补充物品，

·        intended for use in the diagnosis of disease or otherconditions, or in the cure, mitigation, treatment, or prevention of disease, inman or other animals, or

·        旨在用于诊断疾病或其他病症，或用于治疗，缓解，诊治或预防人或其他动物疾病，或，

·        intended to affect the structure or any function of the bodyof man or other animals, and which does not achieve any of its primary intendedpurposes through chemical action within or on the body of man or other animalsand which is not dependent upon being metabolized for the achievement of any ofits primary intended purposes."

·        旨在影响人或其他动物身体结构或任何功能，并且不通过在人或其他动物体内产生化学作用或不依赖任何代谢作用而实现任何预期的目的。”

Does FDAregulate medical devices?

FDA是否监管医疗器械？

Yes, FDAregulates a broad range of medical devices, including complicated, high-riskmedical devices, like artificial hearts, and relatively simple, low-riskdevices, like tongue depressors, as well as devices that fall somewhere inbetween, like sutures. FDA has authority to regulate medical devices before andafter they reach the marketplace.

是的，FDA监管的医疗器械范围很广泛，包括复杂的，高风险的医疗器械，如人造心脏，以及相对简单，低风险的器械，如舌压板，以及缝线。FDA有权在医疗器械到达市场之前和之后对其进行监管。

Do I need aprescription for a medical device?

医疗器械需要处方吗？

Not allmedical devices require a prescription; however, many medical devices dorequire a prescription (for example, contact lenses).

并非所有的医疗器械都需要处方；然而，许多医疗器械需要处方（例如，隐形眼镜）。

Who can writea prescription for a medical device?

谁可以为医疗器械编写处方？

Each statehas laws and regulations that dictate who can write a prescription for amedical device in that state. FDA defers to the states on determining who canwrite a valid prescription.

每个州都有法律和法规，规定谁可以为该州的医疗器械编写处方。FDA推定州政府决定谁可以编写有效的处方。

What is thedifference between FDA-listed, 510(k) exempt, cleared and approved medicaldevices?

FDA名册，510（k）豁免，准许和批准的医疗器械有什么区别？

FDA-listed medicaldevices: A medical device isFDA-listed if the firm that manufactures or distributes the medical device has successfullycompleted an online listing for the device through the FDA UnifiedRegistration and Listing System (FURLS). (While manufacturers arethe entities that typically list medical devices, they are not the onlyentities responsible for doing so.)

FDA名册上的医疗器械：如果制造商或分销医疗器械的公司通过FDA统一注册和列表系统（FURLS）成功完成了该器械的在线列表，则该医疗器械被列入FDA名册。（虽然制造商通常是所列医疗器械的实体，但他们不是唯一负责这样做的实体。）

510(k) exemptmedical devices: Medical devices thatdo not require FDA review before the devices are marketed are considered"510(k) exempt." These medical devices are mostly low-risk, Class Idevices and some Class II devices that have been determined not to require a510(k) (named for a section in the Food, Drug, and Cosmetic Act) to provide areasonable assurance of safety and effectiveness.

510（k）豁免医疗器械：在器械上市之前不需要FDA审查的医疗器械被认为是“510（k）豁免”。这些医疗器械大多是低风险的I类和一些II类器械，这些器械被确定为不需要510（k）（以食品，药品和化妆品法案中的章节命名）提供合理的保证来确保安全性和有效性。

These devices are exempt from complying withpremarket notification requirements subject to the limitations on exemptions;however, they are not exempt from certain general controls. For example, 510(k)exempt devices must

这些器械可以免除遵守售前通知要求，但必须遵守豁免限制；然而，它们不能免除一些一般控制。例如，510（k）豁免器械必须：

·        be suitable for their intended use

·        适用其预期用途

·        be adequately packaged and properly labeled

·        充分包装和正确的标签

·        have establishment registration and device listing forms onfile with FDA

·        有建立注册和器械列表的FDA文件

·        be manufactured under a quality system (with the exception ofa small number of class I devices that are subject only to complaint files andgeneral recordkeeping requirements)

·        在质量体系下生产（除少量I类器械只需符合投诉程序和一般记录要求外）

Cleared medicaldevices: These medicaldevices are ones that FDA has determined to be substantially equivalent toanother legally marketed device. A premarket notification, referred to as a510(k), must be submitted to FDA for clearance. A 510(k) is most oftensubmitted by the medical device manufacturer.

准许的医疗器械：这些医疗器械是FDA已经确定基本上等同于合法销售的器械。售前通知（称为510（k））必须提交给FDA进行放行。510（k）通常由医疗器械制造商进行提交。

Approved medicaldevices: Approved medicaldevices are those devices for which FDA has approved a premarket approval (PMA)application prior to marketing. This approval process is generally reserved forhigh-risk medical devices and involves a more rigorous premarket review thanthe 510(k) pathway.

批准的医疗器械：批准的医疗器械是指在销售前FDA（PMA）程序批准的器械。该审批流程通常保留用于高风险医疗器械，涉及比510（k）途径更严格的上市前审查。

Are medicaldevices regulated for non-medical reasons?

医疗器械是否因非医疗原因而受到监管？

Yes, if the device is an electronic productthat emits (or if unshielded, would emit) electronic product radiation.Manufacturers of such electronic products should be aware that certainradiation protection requirements and recommendations exist under 21 CFRSubchapter J - Radiological Health.

是的，如果器械是具放射性的（或不屏蔽将有放射性）电子辐射产品。这些电子产品的制造商应该知道，21 CFR 子部分J放射性健康下存在的辐射防护要求和建议。

Medical devices are just a subset ofelectronic products that may have general regulatory provisions. Someelectronic product manufacturers have specific performance, reporting, andrecordkeeping standards that must be met before and after their electronicproducts enter into commerce. Examples of the types of electronic productradiations that are regulated include x-rays and other ionizing radiation,ultraviolet, visible, infrared, microwave, radio and low frequency radiation,coherent radiation produced by stimulated emission, and infrasonic, sonic, andultrasonic vibrations.

医疗器械可能只是有一般监管规定的电子产品的子集。一些电子产品制造商在产品进入市场之前和之后必须满足特定的性能，报告和记录，并保持标准。受管制的电子产品的辐射类型包括，x射线和其它电离辐射，紫外线，可见光，红外线，微波，无线电和低频辐射，受激发射产生的相干辐射，以及次声，声波和超声波振动。