1. What is FDA registration
FDA registration, also called FDA registration. Refers to cosmetics, medical devices, food, lasers, LED lamps and other products exported to the United States must register with the United States Federal Food and Drug Administration and ensure that the products meet the relevant US standards and health and safety requirements, some of which must be issued Relevant tests can be registered successfully. For example: Class Ⅱ and Class III clinical medical products must provide 510K documents to register with the FDA.
Common misunderstandings of FDA registration
1. The FDA registration is different from the CE certification. His certification mode is different from the CE certification product testing + reporting certificate mode. The FDA registration actually uses the integrity declaration mode, that is, you are responsible for your products meeting relevant standards and safety requirements. , And register on the US federal website, if the product has an accident, then you must bear the corresponding responsibility. Therefore, for most products, FDA registration does not exist for sending samples for testing and issuing certificates. Therefore, there are many rumors on the Internet that Wahaha has obtained FDA certification and Quanjian products have obtained FDA certification to show that their products are safe. It is a misunderstanding. There is no high-end situation when FDA is established.
2. FDA registration validity period: FDA registration is valid for one year. If it is more than one year, you need to resubmit the registration, and the annual fee involved needs to be repaid.
3. Is there a certificate for FDA registration? : FDA registration in fact all the actions are registered online, there is no certificate said. So what is the FDA certificate circulating in the market? In fact, it is a declaration document issued by the agency itself, proving that the product has been registered with the FDA. Such as:
FDA1.jpg
What is the difference between FDA registration, FDA testing, and FDA certification?
Can be understood like this,
FDA testing generally targets these types of products:
1. Two or three types of medical devices;
2. Cosmetics, daily necessities;
3. Food contact materials;
FDA registration is generally divided into:
Cosmetics
2.LED and laser products
3. Medical devices
4. Food
5. Drugs
FDA certification is a collective name for FDA testing and FDA registration. Both of these can be called FDA certification. FDA certification is just a colloquial term.
4. Latest Developments in FDA Registration
Recently, LED lights will be included in the scope of FDA supervision. It is understood that after the implementation of this rule, LED lamp products may face double "gateway" audits. In addition to customs clearance at the time of customs clearance, FDA approval may also be required. However, this change only concerns the LED lights themselves, and does not involve products using LED lights (such as lamps without the LED lights themselves).
According to industry insiders, LED lights are included in the scope of FDA supervision, and the requirements for the export logistics industry will be more stringent. It is necessary for them to understand the manufacturers and refuse to accept irregular products when receiving customer goods. At the same time, when providing customs clearance materials, it is necessary to provide the LED lamp manufacturer information, including the manufacturer's name, address and contact phone number, to avoid delays in customs clearance.
It is reported that if you only use LED lights but do not have LED lights, you need to clearly mark them in the customs clearance materials.
