Certification Introduction:

FDA (Food and Drug Administration) certification is a certificate of conformity for food or drugs issued by the Food and Drug Administration of the US government. Due to its scientific nature and rigor, this certification has become a world-recognized standard. Drugs certified by the FDA can be sold not only in the United States, but also in most countries and regions in the world. FDA is the abbreviation of the U.S. Food and Drug Administration. It is an authoritative international medical review agency. It is authorized by the U.S. Congress, the federal government, and is the highest law enforcement agency specializing in food and drug administration.

The FDA is a government health regulatory regulatory agency composed of doctors, lawyers, microbiologists, pharmacologists, chemists, statisticians and other professionals dedicated to protecting, promoting and improving national health. Food, drugs, cosmetics and medical devices certified by the FDA are safe and effective for the human body. In nearly 100 countries including the United States, only materials, devices and technologies approved by the FDA can be commercialized for clinical application.

1. FDA testing of food materials

"Food Contact Materials" (abbreviation: FCM) refers to materials that come into contact with food during normal use of products. Because they are in direct contact with food, they are called the "underwear" of food, and their safety directly affects Food safety is also the most critical control point for enterprises. Products involved in food contact materials include food packaging, tableware, kitchen utensils, food processing machinery and kitchen appliances, etc. Food contact materials include:

Plastic, resin, rubber, silicone, metal, alloy, electroplating, paper, cardboard, glass, ceramics, enamel, colorant, printing coating, ink, etc.

Food contact materials and products may affect the smell, taste and color of food during the process of contact with food, and may also release a certain amount of toxic chemical components such as heavy metals and toxic additives. These chemical components will migrate into food and Ingested by the human body, endangering human health.

2. Food FDA testing
3. Medical device FDA testing
4. Cosmetics FDA testing
5. FDA testing of drugs and biological products

Note: LCS business scope is: FDA testing of food materials + FDA testing of laser instruments

application process
1. Consultation---The applicant provides product information pictures or describes the products and materials required to apply for FDA.
2. Quotation --- Based on the information provided by the applicant, the technical engineer will make an evaluation, determine the items that need to be tested, and provide a quotation to the applicant.
3. After confirming the quotation, the applicant fills in the test application form and test samples.
4. Sample testing - testing will be conducted in accordance with 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 products meeting 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.

The difference between FDA certification, FDA testing and FDA registration

It can be understood that FDA testing generally targets these types of products: 1. Class II and III medical devices; 2. Cosmetics and 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 the collective name for FDA testing and FDA registration. Both of these can be called FDA certification. FDA certification is just a colloquial term.

·Which agency issues the FDA certificate?

FDA registration does not have a certificate. The product will obtain a registration number by 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 FDA require designated certified laboratories for testing?

FDA is an enforcement agency, not a service agency. If someone says that they are a certification laboratory affiliated with the FDA, then he is at least misleading consumers, because the FDA has neither public-facing service certification agencies and laboratories nor a so-called "designated laboratory." As a federal law enforcement agency, the FDA cannot engage in such matters as both a referee and an athlete. FDA will only recognize the GMP quality of service testing laboratories and issue certificates of conformity to qualified ones, but it will not "designate" or recommend a specific laboratory or laboratories to the public.

· Does FDA registration require a US agent?

Yes, Chinese applicants must appoint a U.S. citizen (company/society) as their agent when registering with the FDA. The agent is responsible for performing process services in the United States and is the intermediary between FDA and the applicant.

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