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FDA certification in the United States

Introduction to FDA certification

The United States Food and Drug Administration (Food and Drug Administration referred to as FDA), belonging to the health education and Welfare Department, responsible for the national drug, food, biological products, cosmetics, veterinary drugs, Veterinary Bureau of medical equipment and supplies and other diagnostic management of.FDA under the drug administration, Food Bureau, Bureau of Health Bureau of medical devices, and biological products. And diagnostic products bureau and the National Toxicology Research Center, management work area, namely the 6 Bureau (some publications also known as the 6 center), a center and a regional management mechanism. The United States Food and drug administration, a total staff of about 7500 people, 1143 people in the headquarters of the FDA Drug Administration for 350 people.


The United States Food and Drug Administration in Washington D.C. and Lanzhou city Marley Rockwell, large agencies, branches all over the country. In order to strengthen the drug quality management FDA, the country is divided into 6 regions, namely the Pacific region (San Francisco, Seattle, Los Angeles), South West (Dallas, Denver, Kansas). Western District (Chicago, Minneapolis, Detroit), Northeast (Boston, New York, Buffalo), in the District of the Atlantic (Philadelphia, Cincinnati, Newark, Baltimore), Southeast Region (Atlanta, Nashville, New Orleans, Orlando, Dolly the holy wave Ji'an). Each district set up a large area, large area it is provided with a plurality of areas. The Pacific region which is located in San Francisco, southwest region which is located in Dallas, western region region which is located in Chicago, the northeast region is located in the Boston. The large area of the Atlantic is located in Philadelphia, and the large area in the southeast is located in Atlanta


The state management of drug according to the local drug management regulations, the main work is: the examination and registration of pharmacists, supervision and inspection of drug management departments and pharmacies, grant or renew the license, revoke the illegal user license for pharmaceutical colleges and universities the evaluation, review the trainee pharmacies.

Note: FDA is a law enforcement agency, rather than services. If someone says they are under the FDA certification laboratory, then at least he is misleading to consumers, because the FDA is not the membership service certification bodies and laboratories for the public, nor the so-called "designated laboratory".FDA as a federal law enforcement agency in this, not only when the referee, and when athletes do.FDA testing laboratory only to service the GMP quality certification, and qualified certificate, but not to the public "specified", or recommend specific one or several, because which is against the principle of fair competition in American society.


FDA certification mark:



FDA certification bid form

1. food (FOOD): refers to ordinary food, in addition to health inspection, but also need to make nutritional labels. Drinks and canned foods also need to apply for FCE (factory registration), SID (product registration)

2. health food (HEALTHFOOD): also known as functional foods, in addition to the ordinary food import standards, but also need to improve the effectiveness of human body function, but need to do nutritional labeling

3. nutritional supplements (DIETARYSUPPLEMENT): including amino acids, trace elements, vitamins, minerals and herbs, according to FDA law, it can be packaged in drug instructions on the label, manifests the Chinese medicine, health care products, improve the function of the human body, disease prevention for the U.S. FDA certification for composition and packaging and the label has strict requirements.

4. non prescription drugs (OTC): do not need new argument, but the need to provide sufficient materials, in accordance with the laws and regulations that effective components. In the non prescription drugs to FDA requirements, and obtain the drug product export registration number (NDC) after sales to the location of medicine market in the United States.

5. cosmetics (COSMETIC): means to wipe, pour, sprinkle, spray, import or other means used in the human body and any part, in order to achieve cleaning, health care, landscaping, treatment or change the role of facial features

6. Chinese herbal medicine for external use: composed of pure natural plants or extracts. It acts on the body with external forms such as patches, lotions, suppositories and so on. It has the function of health care and treatment

7.GMP certification: domestic pharmaceutical raw material drug to legitimate access to the American market to American FDA certification GMP certification GMP certification. The United States is also the products to the international market. To pass through two stages:

(1) compiling DMF (DRUGMASTERFILE) and reporting to the United States FDA, and obtaining the DMF registration number

(two) American FDA officials inspected and certified on the spot


FDA certification requires the list of documents to be submitted and the certification cycle

List of documents to be submitted for FDA authentication:

1, < < agreement > > (signed by legal representative and stamped with company chop)

2, legal status documents (business license, business legal person code certificate, etc., copy with official seal)

3, within the validity of the qualification certificate or production license (copy with official seal)

4, formal application

5, product manual

6, product technical manual

7, product related drawings

8, FDA new additions required to submit other documents (if any)


FDA certification cycle: different product FDA certification cycle is not the same, the general FDA certification cycle is 10--50 working days

FDA certification scope

With all the direct contact with food and beverage, or direct contact with the population of the tongue, containers, materials, etc., must pass the FDA certification standards of testing and certification before entering the U.S. market

1, food packaging materials FDA testing certification: paper, plastic film, plastic aluminum foil

2, glass ceramic products FDA testing certification: all kinds of glass and ceramic pots, bowls, plates, spoons, pots, cups, bottles, pots and other products

3, food grade plastic products FDA certification: plastic materials in contact with food or direct entrance include: nylon, ABS, ACRY, PU, PE, PC, PVC, PP, PR, PET, PO, PS, PSU, POM, PPS, EVA, SAN, SMM, EVA, BS. MEL, COPP, KRAT, ACRY and so on.

4, food

5, medical instruments

6, drugs

7, food additives

8, drinks

9, food related materials

10, coating products FDA testing certification: coated in food contact surface of paraffin copolymer, PVC coating, powder coating, ink and so on

11, plumbing hardware products FDA testing certification: with drinking water, tap water contact taps, pipes, containers, valves, water heaters and so on

12, rubber resin products FDA testing certification

13, sealing material FDA testing certification

14, chemical additives, FDA testing certification: pigment, preservatives, antioxidants, surfactants and so on

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