What is FDA register？

　　Food and Drug Administration for short FDA,FDA be in charge of:food,medicine（Including veterinary drugs）,Medical instrument,Food additives,cosmetics、Animal food and medicine,Supervision and inspection of wine beverages containing less than 7% alcohol and electronic products.

　　So these categories of products If it's listed on Amazon, it has to be registered with the FDA.

　　If a company applies to the FDA, It starts with an American agent。

　　United States agent definition：An agent of the United States is someone who has a presence in the United States or has a business presence in the United States，Foreign factories appoint them as registered agents for FDA registration.FDA regulation,Foreign medical device manufacturers must register before entering the United States,An American agent must also be appointed,The U.S. agent is responsible for emergency and routine communications.

　　Duty of U.S. agent：U.S. agents act as a communication link between FDA and foreign factories,Responsible for emergency and routine communication.When there is an emergency,The FDA will contact a U.S. agent,Unless another person is designated as the emergency contact during registration.American agents represent foreign factories,FDA will treat the U.S. agent's representation as that of a foreign plant,Information or documents provided to a U.S. agent will be considered equivalent to information or documents provided to a foreign factory.

　　Several categories of FDA registration?

　　1、Food and FDA registration

　　There are some differences with the medical device FDA registration：

　　①Food to FDA do not need to pay US $annual fee

　　② It is updated every even year

　　③There is no public query method after the successful registration of Food and FDA, you need to log in the background with the user name and password to query

　　Food and FDA registration steps：

　　Step 1: Confirm whether the product is under FDA food control

　　Step 2: Choose a US AGENT

　　Step 3: Prepare enterprise English information and product English information

　　The registration number of the enterprise will be obtained after the successful registration of the food. The fee includes the payment of the registration and the service of the American agent. The cycle is 3-5 working days

　　2、Medical device FDA registration

　　Including enterprise registration and product listing two parts.

　　After registration, you can enter the corresponding registration code, query code, or enterprise name to find the relevant information on FDA.

　　The cost includes two aspects:

　　One is the annual FDA fee charged in the United States,This should be paid directly to FDA in the form of US dollars. The annual fee for the next year should be renewed from October 1st to December 31st each year to maintain the validity of FDA registration. The amount of annual fee is also different every year.

　　The other is the agency fee (which includes company registration, product registration, and United States agent).

　　After successful registration, there will be three numbers:

　　①Registration or FEI Number

　　② Operator Number

　　③Listing Number

　　It is the most cost-effective for enterprises to register with FDA from October to December each year. If they register with FDA after October 1, the registration number can be used until the end of the next year. If they pay an annual fee for one year, the registration number can be extended for 3 months.

　　The registration period of FDA is 1-2 weeks (after the registered enterprise successfully pays the annual fee to FDA).The Owner/Operator Number and the product registration Number isting Number are listed first,It can be cleared directly.Registered devices that have not yet received a Medical Device Facility Registration number,This number may be temporarily used as the "Medical Device Facility Registration Number" for export declaration.Among them,Registration or FEI Number Need to wait for FDA distribution。

　　3、Cosmetic registration

　　There are two types of FDA cosmetic registrations: factory registrations and product registrations

　　① Factory registration: Apply for the account first, submit the registration after FDA confirmation, and FDA approval, the cycle is 2 weeks.

　　② Product registration: the premise of product registration is to register the factory first, and then submit the product ingredients. The cost of ingredient registration is multiplied with the ingredients.

　　After the successful registration of cosmetics, the enterprise registration number and the registration number of CPIS product ingredients will be obtained (cosmetics registration is similar to food, which needs to be checked in the background, but cannot be directly queried).

　　4、Food contact material FDA test report

　　Step 1: Test according to FDA standard and get test report

　　Step 2: After getting the test report, we will go to the FDA database as the US agent of your company to check whether the corresponding standards meet the relevant requirements of FDA. And then the compliance certificate will eventually get the FDA compliance certificate

　　5、Expiration date of FDA certification /FDA registration

　　① Cosmetic FDA

　　This parameter is valid after the authentication is successful

　　All cosmetics sold in the United States, whether locally manufactured or imported, must comply with regulations issued by the Law and Regulatory Commission, which require a voluntary registration program for cosmetics.

　　② Medical device FDA

　　Valid for one year, renewed in October each year

　　The U.S. Food and Drug Administration (FDA) Modernization Act requires all businesses engaged in the manufacture, preparation, distribution, synthesis, assembly, processing, or import and export of medical devices to be registered with the FDA.

　　③ Laser radiation FDA

　　Valid for one year, renewed in July each year

　　Laser varieties include: laser pointer, laser demonstration, laser display, containing laser unit products (DVD, CD-ROM, CD player, laser printer, etc.) safety protection and rescue products.