FDA检测和注册的产品大概可以分为这几种：医疗器械,、药品、食品、化妆品、激光（LASER)类产品和与食品接触材料测试（TestMeasure)(即食品级测试)，对于所有与食品饮料直接接触，或者直接与人口舌接触的器皿，材料等，都必须通过FDA标准的检测认证，才能进入美国市场。
医疗器械FDA注册
包括企业注册和产品列名两个部分。
注册完成后输入相应的注册码、查询码、或者企业名称可以到FDA上查询到相关信息。
费用包括两个方面，一个是美国收取的FDA年费，这个要用以美金的形式直接付给FDA财政，每年的10月1号-12月31号续交下一年的年费，以维持FDA注册的有效性，年费的金额每年也都不一样。（一类医疗器械年费目前是5546美元，平均每年涨数百美元）
另一个是收取的代理费用（是包含了公司登记，产品注册，美国代理人）。
注册成功后会有三个号码：
①、医疗器械设施登记号Registration or FEI Number
②、产权人识别号Owner/Operator Number
③、产品注册号码Listing Number
企业选择在每年的10月-12月进行FDA注册是zui划算，10月1号之后注册FDA，注册号可持续使用到下一年年底，交一年的年费，注册号可多用3个月。
FDA注册周期为1-2周（注册企业向美国FDA成功支付年费后），先会有产权人识别号Owner/OperatorNumber和产品注册号码istingNumber，直接可以清关。登记过但还没有获得“医疗器械设施登记号”的设备，可以临时以这个号码作“医疗器械设施登记号”用于出口报关。其中，Registrationor FEI Number需要等FDA分配。
The products tested and registered by FDA can be roughly dividedinto the following categories: medical devices, drugs, food,cosmetics, laser (LASER) products and food contact materials (i.e.food grade test). All containers and materials that directlycontact with food and beverage or peoples tongue must pass the FDAstandard test certification before entering the U.S. market.
FDA Registration of Medical Devices
Including enterprise registration and product listing.
After registration, enter the corresponding registration code,query code, or enterprise name to query relevant information onFDA.
The fee includes two aspects. One is the annual fee of FDAcharged by the United States, which is directly paid to the FDAfinance in the form of US dollars. The annual fee of the next yearis renewed from October 1 to December 31 each year to maintain thevalidity of FDA registration. The amount of the annual fee isdifferent every year. (The annual fee for Class I medical devicesis currently $5546, with an average annual increase of hundreds ofdollars)
The other is the agency fee charged (including companyregistration, product registration and American agent).
After successful registration, there will be three numbers:
① Registration or FEI Number
② Owner/Operator Number
③ Listing Number
It is the most cost-effective for enterprises to choose toregister FDA in October December of each year. After October 1,they can register FDA. The registration number can be usedcontinuously until the end of the next year. They can pay an annualfee for one year. The registration number can be used for threemore months.
The FDA registration cycle is 1-2 weeks (after the registeredenterprise successfully pays the annual fee to the FDA of theUnited States). First, there will be the owner/operator number andthe product registration number, which can be used for customsclearance. For the e that has been registered but has notobtained the "medical device facility registration number", thisnumber can be temporarily used as the "medical device facilityregistration number" for export declaration. Registration or FEINumber needs to be allocated by FDA.
