Food FDA Certification
The FDA's regulatory agency for food, produce, and seafood is the Center for Food Safety and Nutrition (CFASAN), whose responsibility is to ensure that Americans' food supply is safe, clean, fresh, and clearly labeled.
Medical Device FDA Approval
The FDA regulates medical devices through the Center for Devices and Radiological Health (CDRH), which oversees the manufacturing, packaging, and distributing of medical devices in compliance with the law.
Medical devices range from small medical gloves to large cardiac pacemakers, and are all under FDA oversight. Based on medical use and possible harm to the human body, the FDA categorizes medical devices into Class I, II, and III, with the higher the category the more oversight.
If the product is a novel invention that does not exist in the marketplace, the FDA requires the manufacturer to conduct rigorous human trials and have compelling medical and statistical evidence of the product's effectiveness and safety.
The FDA certification of medical devices, including: manufacturers registered with the FDA, the product's FDA registration, product listing registration (Form 510 registration), product marketing review and approval (PMA review) Labeling and technical modifications of healthcare devices, customs clearance, registration, pre-market reports, the following materials must be submitted: (1) five copies of the finished product with complete packaging, (2) a diagram of the construction of the device and its Text description, (3) performance and working principle of the device, (4) safety demonstration or test material of the device, (5) brief description of the manufacturing process, (6) summary of clinical trials, (7) product specification. If the device has radioactive energy or release of radioactive material, must be described in detail.
Cosmetic FDA certification
Voluntary Cosmetic Registration Program (VCRP)
The FDA Office of Cosmetics and Pigmentation at the request of the cosmetic industry to develop a voluntary cosmetic registration program. The program consists of two parts: voluntary registration of cosmetic manufacturers and cosmetic ingredient declarations.
FDA Approval of Drugs
The FDA has a comprehensive approval process for pharmaceutical products to ensure the safety and effectiveness of new drugs. The process is as follows:
1. Investigational New Drug Application (IND):
The FDA's monitoring of a new drug begins when a pharmaceutical company submits an IND to the FDA. At this time, human trials have not yet begun, and the FDA reviews in vitro safety data and animal testing data to determine whether the drug is safe enough to enter human trials.
2. Human trials:
Human trials*** are divided into four phases. The first phase mainly tests the safety of the drug, the main side effects, metabolic mechanism, etc., the sample size is generally less than 00.
The second phase of the main test of the effectiveness of the drug, in order to determine whether the drug can be effective in the human body. At the same time, the safety and toxicity of the drug is also closely observed. The sample size for Phase II trials is usually less than 300.
If the Phase II trials are encouraging, larger samples will be tested and the trial will proceed to Phase III. Phase III will include different age groups, different populations, and different dosages of the drug in order to fully investigate the safety and efficacy of the drug. The number of samples in Phase III will range from a few hundred to a few thousand.
Phase IV trials are conducted after a new drug has been approved and test the long-term safety of the drug in new populations.
3. New Drug Application (NDA):
When a pharmaceutical company completes human trials and verifies the safety and efficacy of a new drug, it formally submits an NDA application to the FDA. The FDA reviews all animal and human trial data, as well as data on the drug's mechanism of dissolution, and GMP data on the drug's production. If the data are incomplete or unreasonable, the FDA will reject the application; otherwise, the FDA will complete the application in 10 months or so, and will give an opinion of approval or rejection.
Food contact products and 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 a variety of plastics, metal, ceramics, glass, bamboo and wood products, etc. The environmental safety of these materials in contact with food is directly related to the user's dietary safety and health, so the export of such products to the U.S. needs to be in accordance with the FDA standards for the relevant testing and certification
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