近期，有客戶問到動物器械出口美國是否需要申請FDA注冊相關話題，考慮到寵物市場和消費群體日益龐大，動物器械市場也是與日俱增，因此，寫個文章說說這個事。
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 如何監管動物器械
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.
《聯邦食品、藥品和化妝品法案》（該法案）將醫療器械定義為“儀器、裝置、工具、機器、設備、植入物、體外試劑或其他類似或相關物品，包括任何組件、部件或附件，這些物品......用于診斷疾病或其他狀況，或用于治愈、緩解、治療或預防人類或其他動物的疾病，或[旨在] 影響人類或其他動物身體的結構或任何功能......”。此外，設備“不能通過人或其他動物體內或體內的化學作用來實現其主要預期目的，并且......不依賴于被代謝以實現其主要預期目的。設備的示例包括針頭、注射器、手術器械、假肢設備、X 射線設備、某些診斷測試套件和牙科器具等。
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 確實對用于動物的器械進行監管，如果動物器械貼錯標簽或摻假，FDA 可以采取適當的監管行動。
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.
不需要上市前批準： FDA 不要求提交 510（k）、PMA 或任何動物用器械的上市前批準。
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.
專門生產或分銷動物器械的器械制造商無需向 FDA 注冊其企業或列出動物器械，并且無需進行上市后報告。這些物品的制造商和/或分銷商有責任確保這些動物器械安全、有效且貼有適當的標簽。
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 鼓勵獸醫和動物主人使用 FDA 1932a 表格向 FDA 報告與動物器械相關的不良藥物經歷和產品缺陷。
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 中針對輻射發射電子產品的適用要求外，同時屬于輻射發射電子產品的動物器械（如動物用 MRI 設備）還必須符合所有動物器械要求。FDA 的器械和放射健康中心 （CDRH） 負責監管發射輻射的電子產品。有關適用于電子產品制造商的 CDRH 法規的更多信息，請訪問 FDA 的輻射發射商品網站。