What Is FDA Certification | Best Guidance-Xiongda

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FDA certification , Food and Drug Administration, is one of the executive agencies of the U.S. government established in the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS).

FDA’s responsibility is to ensure the safety of food, cosmetics, drugs, biologicals, medical devices and radiological products manufactured in or imported into the United States. It was one of the first federal agencies to have consumer protection as its primary function.


FDA certification


FDA certification format

FDA registration

Many products sold to the United States need to be registered (such as food, drugs, medical devices, laser products, etc.), some products must be tested to apply for registration.

FDA testing

In accordance with FDA regulations on product testing.

FDA-managed products are mainly food, drugs, medical devices, microbial products, pet food and drugs, including cosmetics, radiation products, combination products and other personal health and safety related to electronic products and medical products.

The United States FDA certification means

  1. Products exported to the United States, the FDA is a mandatory requirement, companies must complete the FDA registration or testing before exporting to the United States.
  2. Recognized by some small countries, because small countries do not have their own regulatory requirements, will rely on the regulations of large countries to regulate exporters; 3. in the same industry, the product of the FDA certification.
  3. In the same industry products to enhance product competitiveness.


FDA certification


What are the FDA certification standards?

The U.S. Food and Drug Administration (FDA) lists three categories of food additives:

  1. Direct food additives: directly added to the ingredients in food; 
  2. Secondary direct food additives: ingredients added to food during food processing, for example, with ionic resins, solvent extraction treatment of food.
  3. Indirect food additives: substances that may come into contact with food as part of packaging or processing equipment, but are not added directly to food.

Note: only “indirect food additives” and food contact materials.

FDA certification information to prepare

  1. The name of the product: to provide the full name of the product;
  2. Product model: a detailed list of all the products need to carry out experiments such as model, species or classification number;
  3. Parts list: detailed list of parts and components that make up the product model (classification number), rating, manufacturer’s name, for insulation materials, please provide the name of the raw material.
  4. Electrical properties: for electronic and electrical products, provide the electrical schematic diagram (wiring diagram), electrical performance table;
  5. Structural drawings: for most products, provide the product’s structural drawings or exploded diagrams, ingredient lists, etc.;
  6. Product photos, instructions, safety and other items or installation instructions, such as samples do not allow the demolition of the laser head to provide pictures.


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