近期，有客戶(hù)問(wèn)到動(dòng)物器械出口美國(guó)是否需要申請(qǐng)F(tuán)DA注冊(cè)相關(guān)話題，考慮到寵物市場(chǎng)和消費(fèi)群體日益龐大，動(dòng)物器械市場(chǎng)也是與日俱增，因此，寫(xiě)個(gè)文章說(shuō)說(shuō)這個(gè)事。
近期，有客戶(hù)問(wèn)到動(dòng)物器械出口美國(guó)是否需要申請(qǐng)F(tuán)DA注冊(cè)相關(guān)話題，考慮到寵物市場(chǎng)和消費(fèi)群體日益龐大，動(dòng)物器械市場(chǎng)也是與日俱增，因此，寫(xiě)個(gè)文章說(shuō)說(shuō)這個(gè)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(jiān)管動(dòng)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(lián)邦食品、藥品和化妝品法案》（該法案）將醫(yī)療器械定義為“儀器、裝置、工具、機(jī)器、設(shè)備、植入物、體外試劑或其他類(lèi)似或相關(guān)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(yù)防人類(lèi)或其他動(dòng)物的疾病，或[旨在] 影響人類(lèi)或其他動(dòng)物身體的結(jié)構(gòu)或任何功能......”。此外，設(shè)備“不能通過(guò)人或其他動(dòng)物體內(nèi)或體內(nèi)的化學(xué)作用來(lái)實(shí)現(xiàn)其主要預(yù)期目的，并且......不依賴(lài)于被代謝以實(shí)現(xiàn)其主要預(yù)期目的。設(shè)備的示例包括針頭、注射器、手術(shù)器械、假肢設(shè)備、X 射線設(shè)備、某些診斷測(cè)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(shí)對(duì)用于動(dòng)物的器械進(jìn)行監(jiān)管，如果動(dòng)物器械貼錯(cuò)標(biāo)簽或摻假，F(xiàn)DA 可以采取適當(dāng)?shù)谋O(jiān)管行動(dòng)。
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(zhǔn)： FDA 不要求提交 510（k）、PMA 或任何動(dòng)物用器械的上市前批準(zhǔn)。
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(zhuān)門(mén)生產(chǎn)或分銷(xiāo)動(dòng)物器械的器械制造商無(wú)需向 FDA 注冊(cè)其企業(yè)或列出動(dòng)物器械，并且無(wú)需進(jìn)行上市后報(bào)告。這些物品的制造商和/或分銷(xiāo)商有責(zé)任確保這些動(dòng)物器械安全、有效且貼有適當(dāng)?shù)臉?biāo)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(lì)獸醫(yī)和動(dòng)物主人使用 FDA 1932a 表格向 FDA 報(bào)告與動(dòng)物器械相關(guān)的不良藥物經(jīng)歷和產(chǎn)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(duì)輻射發(fā)射電子產(chǎn)品的適用要求外，同時(shí)屬于輻射發(fā)射電子產(chǎn)品的動(dòng)物器械（如動(dòng)物用 MRI 設(shè)備）還必須符合所有動(dòng)物器械要求。FDA 的器械和放射健康中心 （CDRH） 負(fù)責(zé)監(jiān)管發(fā)射輻射的電子產(chǎn)品。有關(guān)適用于電子產(chǎn)品制造商的 CDRH 法規(guī)的更多信息，請(qǐng)?jiān)L問(wèn) FDA 的輻射發(fā)射商品網(wǎng)站。