1. Consultation---the applicant provides product information pictures or describes the products and materials that need to apply for FDA.
2. Quotation---Based on the information provided by the applicant, the technical engineer will make an assessment, determine the items to be tested, and quote the applicant
3. After the applicant confirms the quotation, fill in the test application form and test samples
4. Sample testing-the test will be carried out in accordance with the applicable FDA standards
5. Provide FDA certification report after the test is completed
About FDA certificate
FDA registration actually adopts the integrity declaration model, that is: you are responsible for your product to meet the relevant standards and safety requirements, and register on the US federal website.
Does FDA registration have a certificate: In fact, all actions of FDA registration are registered online, and there is no such thing as a certificate. So what is the FDA certificate circulating on the market? In fact, it is a declarative document issued by the agency itself, proving that the product has been registered with the FDA.
Differences between FDA certification, FDA testing and FDA registration
It can be understood that FDA testing is generally targeted at the following categories of products: 1. Class II and Class III medical devices; 2. Cosmetics, daily necessities; 3. Food contact materials;
FDA registration is generally divided into: 1. Cosmetics 2. LED and laser products 3. Medical devices 4. Food 5. Drugs
FDA certification is a general term for FDA testing and FDA registration. Both can be called FDA certification. FDA certification is just a colloquial term.
Others
· Which agency issues the FDA certificate?
FDA registration does not have a certificate. Products will obtain a registration number after registering with the FDA. The FDA will give the applicant a reply letter (with the signature of the FDA Chief Executive), but there is no such thing as an FDA certificate.
· Does the FDA need a designated certification laboratory for testing?
FDA is an enforcement agency, not a service agency. If someone says that they are a certification laboratory under the FDA, then he is at least misleading consumers, because the FDA has neither a public service certification agency and laboratory, nor a so-called "designated laboratory". As a federal law enforcement agency, the FDA cannot engage in such things as both a referee and an athlete. FDA will only recognize the GMP quality of service testing laboratories and issue certificates of compliance to qualified laboratories, but will not "designate" or recommend a specific one or several to the public.
· Does FDA registration require a US agent?
Yes, Chinese applicants must appoint a US citizen (company/association) as their agent when registering with the FDA. The agent is responsible for the process services in the United States and is the medium for contact between the FDA and the applicant.
