摘要：Recently, a customer asked if it is necessary to apply for FDA registration for the export of animal equipment to the United State

近期，有客户问到动物器械出口美国是否需要申请FDA注册相关话题，考虑到宠物市场和消费群体日益庞大，动物器械市场也是与日俱增，因此，写个文章说说这个事。

Recently, a customer asked if it is necessary to apply for FDA registration for the export of animal equipment to the United States. Considering the increasingly large pet market and consumer group, the animal equipment market is also growing day by day. Therefore, I would like to write an article to talk about this matter.

How FDA Regulates Animal Devices/FDA 如何监管动物器械

The Federal Food, Drug, and Cosmetic Act (the Act) defines medical device as "an instrument, apparatus, implement, machine, contrivance, implant, in-vitro reagent, or other similar or related article, including any component, part, or accessory, which is ... intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals, or [which is] intended to affect the structure or any function of the body of man or other animals ... ." Further, a device "does not achieve its primary intended purposes through chemical action within or on the body of man or other animals, and ... is not dependent upon being metabolized for the achievement of its primary intended purposes." Examples of devices include such things as needles, syringes, surgical instruments, prosthetic devices, X-ray equipment, certain diagnostic test kits, and dental appliances.

《联邦食品、药品和化妆品法案》（该法案）将医疗器械定义为“仪器、装置、工具、机器、设备、植入物、体外试剂或其他类似或相关物品，包括任何组件、部件或附件，这些物品......用于诊断疾病或其他状况，或用于治愈、缓解、治疗或预防人类或其他动物的疾病，或[旨在] 影响人类或其他动物身体的结构或任何功能......”。此外，设备“不能通过人或其他动物体内或体内的化学作用来实现其主要预期目的，并且......不依赖于被代谢以实现其主要预期目的。设备的示例包括针头、注射器、手术器械、假肢设备、X 射线设备、某些诊断测试套件和牙科器具等。

FDA does have regulatory oversight over devices intended for animal use and can take appropriate regulatory action if an animal device is misbranded or adulterated.

FDA 确实对用于动物的器械进行监管，如果动物器械贴错标签或掺假，FDA 可以采取适当的监管行动。

Pre-market Approval is Not Required: The FDA does not require submission of a 510(k), PMA, or any pre-market approval for devices intended for animal use.

不需要上市前批准： FDA 不要求提交 510（k）、PMA 或任何动物用器械的上市前批准。

Device manufacturers who exclusively manufacture or distribute animal devices are not required to register their establishments or list animal devices with FDA and are exempt from post-marketing reporting. It is the responsibility of the manufacturer and/or distributor of these articles to assure that these animal devices are safe, effective, and properly labeled.

专门生产或分销动物器械的器械制造商无需向 FDA 注册其企业或列出动物器械，并且无需进行上市后报告。这些物品的制造商和/或分销商有责任确保这些动物器械安全、有效且贴有适当的标签。

The FDA encourages veterinarians and animal owners to report adverse drug experiences and product defects associated with animal devices to FDA using Form FDA 1932a.

FDA 鼓励兽医和动物主人使用 FDA 1932a 表格向 FDA 报告与动物器械相关的不良药物经历和产品缺陷。

An animal device that is also a radiation emitting electronic product, such as an MRI device intended for animal use, must comply with all requirements for animal devices in addition to applicable requirements for radiation-emitting electronic products in 21 CFR 1000 - 1050. FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating radiation-emitting electronic products. For further information on CDRH regulations that apply to manufacturers of electronic products, visit FDA’s website on Radiation Emitting Products.

除了 21 CFR 1000 - 1050 中针对辐射发射电子产品的适用要求外，同时属于辐射发射电子产品的动物器械（如动物用 MRI 设备）还必须符合所有动物器械要求。FDA 的器械和放射健康中心 （CDRH） 负责监管发射辐射的电子产品。有关适用于电子产品制造商的 CDRH 法规的更多信息，请访问 FDA 的辐射发射商品网站。

来源：瞌睡小熊爱科学