I. FDA Definition
The U.S. Food and Drug Administration (FDA) was established in 1906. It is one of the executive agencies of the U.S. government within the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS). As a scientific regulatory agency, the 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. Internationally, the FDA is recognized as one of the world's largest food and drug regulatory agencies. Many other countries promote and monitor the safety of their products in that country by seeking and receiving help from the FDA.
Second, FDA certification mainly refers to the following two kinds:
1, FDA registration: many products sold to the United States need to be registered (such as food, cosmetics, drugs, medical devices, laser products, etc.), some products must also be tested to apply for registration.
2, FDA testing: is in accordance with FDA regulations for product testing. (Food contact materials, cosmetics and daily necessities FDA testing)
Third, the role of FDA certification:
FDA has a profound impact in the United States and the world, with the name of the patron saint of American health. Declared products need to be used on the human body after the product for monitoring key testing sites, 2-3 million people for 3-7 years of continuous monitoring, all passed the product, FDA certification will be issued. Therefore, FDA certification is recognized by the World Health Organization as a food safety standard. Is the international manufacturers to pursue the honor and guarantee.
Fourth, the FDA needs to specify the certification laboratory testing?
FDA is an enforcement agency, not a service agency. The FDA, as a federal law enforcement agency, cannot engage in this kind of thing as both a judge and an athlete. Qualified to issue a certificate of compliance, but will not "designate" to the public, or recommend a specific one or several.
V. FDA certification scope, cycle, cost
1、Food FDA certification
FDA food, agricultural products, seafood management agency is the Center for Food Safety and Nutrition (CFSAN), whose responsibility is to ensure that the American food supply is safe, clean, fresh and clearly marked.
Food FDA certification is relatively simple, prepare a product specification on it, if it is canned food, but also need to provide information on product packaging and production sterilization.
Food FDA certification generally takes 3-5 working days to complete, different food costs are different, such as low-acid canned food, new meals, etc. will be higher than the general food costs, long lead time, so the specific costs need to provide customers with product information and ingredients to Crown inspection business, in order to give the specific costs required.
2、FDA certification for medical devices
FDA's management of medical devices through the Center for Devices and Radiological Health (CDRH), the Center oversees the production of medical devices, packaging, distributors to comply with the law under the business activities. The range of medical devices is wide, from small medical gloves to large cardiac pacemakers, all under the supervision of the FDA. According to the medical use and possible harm to the human body, the FDA classifies medical devices into Ⅰ, Ⅱ and Ⅲ categories, the higher the category the more supervision.
For Class I products, after enterprises submit relevant information to the FDA, the FDA will only make announcements and no relevant documents will be issued to enterprises; for Class II and III devices, enterprises must submit PMN or PMA, and the FDA will give enterprises a formal market access approval letter (Clearance) at the same time of announcement, which allows enterprises to sell their products directly in the U.S. medical device market under their own names. As for whether to conduct on-site GMP examination at the enterprise during the application process, it is decided by FDA based on a combination of factors such as product risk level, management requirements and market feedback.
Medical device FDA certification depends on the product requirements. 510k exemption is relatively simple, 510k is more difficult to do, need to send samples for testing. pma is more difficult.
3, cosmetics FDA certification
FDA Office of Cosmetics and Pigments at the request of the cosmetics industry to develop a voluntary registration program for cosmetics (VCRP). The program consists of two parts: voluntary registration of cosmetic manufacturers and cosmetic ingredient declaration.
Cosmetic FDA certification requires the preparation of product formulations can
The cost of FDA certification for cosmetics is our service fee, you need to provide the product formulations to Crown Pass testing business to give the required service fee, the cycle is generally about a month!
4、Pharmaceuticals, biological products FDA certification
FDA has a complete set of certification procedures for pharmaceutical products to ensure the safety and effectiveness of new drugs.
FDA certification of drugs need to look at non-prescription drugs, prescription drugs or new drugs, more difficult and more information.
FDA certification of drugs can be said to be much more complex than food, where the drug FDA certification in the broad categories of prescription drugs and non-prescription drugs! The cost and cycle of prescription drugs can not give you a brief introduction here, the cost is higher and the cycle is very long, requiring a lot of testing! Over-the-counter drugs, which are our common OTC drugs, generally two weeks to complete the FDA certification, the specific cost or need to communicate with the Crown testing business to understand!
a, investigational new drug application (IND);
b, human experiments: human experiments are divided into four stages;
c, new drug application New Drug Application (NDA), Biologic License Application (BLA).
5, food materials FDA certification
Food contact materials refer to all materials used in the processing, production, packaging, storage and transportation of food, and food can come into contact with the material. Common materials include various plastics, metals, ceramics, glass, bamboo and wood products. The environmental safety of these materials in contact with food is directly related to the user's food safety and health. Therefore, the export of these products to the United States need to be in accordance with FDA standards for testing and certification.
6、Laser FDA certification
FDA recognizes the four main hazard categories of laser (I to IV), including three subcategories (IIa, IIIa and IIIb), the higher the level, the more powerful the laser, if used improperly, the greater the possibility of serious injury, II-IV label must include a warning symbol, indicating the level of the product and the output power, for products labeled under the International Electrotechnical Commission classification system. including the roughly equivalent IEC rating.
Laser products FDA certification requires the preparation of a lot of information, product specifications, wiring diagrams, etc.
Laser products FDA certification costs need to be based on the level of laser products to determine the specific price, you need to provide product details to Guan Tong testing to give specific costs, the general cycle of 2 weeks to complete!
Six, the certification process is as follows:
1. provide product information, determine and determine the application path;
2. Fill out the FDA application form;
3. Sign the contract and pay the agent fee;
4. Pay the U.S. dollars to the U.S. FDA;
5. Submit registration application information to the FDA for approval;
6. Registration approval is completed and approval number is obtained;
7. issue the registration certificate;
8. Time about 2 weeks.
