The U.S. Food and Drug Administration (Food and Drug Administration) referred to FDA.
FDA is the U.S. Government Department of Health and Human Services (DHHS) and the Ministry of Public Health (PHS) in the establishment of executive agencies.
As a scientific management agency, FDA's role is to ensure that the U.S. domestically produced or imported food, cosmetics, drugs, biologics, medical devices and radiation safety. It is the earliest in order to protect consumers as one of the main functions of federal agencies. The institutions and the lives of every American citizen are closely related. In the international arena, FDA is recognized as the world's largest food and drug regulatory agencies. Many other countries have adopted the FDA to seek and receive help to promote and monitor the safety of their own products.
Food and Drug Administration (FDA) Supervisor: food, medicine (including veterinary), medical devices, food additives, cosmetics, animal food and drugs, alcohol content of less than 7% of wine beverages as well as supervision and inspection of electronic products; also cosmetics , radioactive products, combination products and personal health and safety of electronic products and medical products. Products in use or consumption ions generated in the process of non-ionizing radiation affect human health and safety programs of testing, inspection and certification. According to regulations, the product must undergo FDA testing to prove safety, before they can be marketed. FDA has the right to inspect the manufacturer, the right to prosecute offenders. According to the different regulatory product range can be divided into the following main regulatory bodies:
1. Food Safety and Applied Nutrition (CFSAN):
The center is the largest sector of the workload FDA. It is responsible for the jurisdiction of the U.S. Department of Agriculture in addition to meat, poultry and eggs outside of the United States food safety. Although the United States is the world's food supply the safest countries, but every year there are about seventy-six million foodborne illnesses occur, thirty 25,000 foodborne illness requiring hospitalization, five thousand or so people died of foodborne illness. Food Safety and Nutrition Center is committed to reducing foodborne illness, and promote food safety. And to promote a variety of programs, such as: HACCP plan to promote implementation.
The center's functions include: ensuring substances added to food security and pigment; ensure through the development of biotechnology in food and the safety of ingredients; responsible for the correct identification of food (such as composition, nutritional health claims) and cosmetics management activities; develop appropriate policies and regulations to manage dietary supplements, infant formula and medical foods; ensure the safety of cosmetic ingredients and products to ensure proper identification; supervise and regulate the food industry sales behavior; consumer education and behavioral development; and state and local government cooperation projects; coordination of international food standards and safety.
2. Center for Drug Evaluation and Research (CDER):
The center aims to ensure prescription and non-prescription drugs safe and effective, the new drug before it is evaluated and supervision on the market a thousand kinds of medicines in order to ensure that products meet the highest standards constantly updated. Meanwhile, the center also controls television, radio, and publications on the authenticity of pharmaceutical advertising. Strict supervision of medicines, to provide safe and accurate information to consumers.
3. equipment safety and radiation protection of health centers (CDRH):
The center of the new listings in ensuring the safe and effective medical devices. Because the world there are more than twenty thousand production from glucose monitors to artificial heart valves, etc. more than eighty thousand kinds of different types of medical devices. These products are closely related to the lives of my colleagues, so that the center also regulated nationwide after-sales service. For some such as microwave ovens, televisions, mobile phones and other products that produce radiation, the center also identified a number of appropriate safety standards.
4. Center for Biologics Evaluation and Research (CBER):
The central monitoring and treatment of diseases that can prevent biological products, so more than more complex chemical synthesis drugs, which include blood, plasma, vaccines and other safety and effectiveness of scientific research.
5. Center for Veterinary Medicine (CVM):
FDA certification Introduction
Food FDA certification
FDA for food, agricultural products, seafood is administered through the Center for Food Safety and Nutrition (CFASAN), whose role is to ensure that American food supply safe, clean, fresh and clearly marked.
Central oversight of food imports $ 240 billion per year, of which 15 billion are imported food, the center's main monitoring highlights include:
1. food freshness;
2. food additives;
3. food biological toxins or other harmful ingredients;
4. seafood safety analysis;
5. food labeling;
6. after the listing of food tracking and alerts
According to the U.S. Congress in 2003 had anti-terrorism law, outside of the U.S. food exports to the United States in front of companies must register with the FDA and export freight notification to the FDA.
Accordance with the "U.S. Public Law No. 107-188," FDA must be registered foreign food production and processing enterprises are as follows:
1. including wine and alcoholic beverages;
2. baby and children's food;
3. bread cakes;
4. beverages;
5. sweets (including chewing gum);
6. cereals and instant oatmeal category;
7. cheese and cheese products;
8. chocolate and cocoa food;
9. coffee and tea products;
10. food coloring;
11. slimming conventional food and medicinal foods, meat substitutes;
12. supplementary food (ie domestic health food, vitamins, herbal medicines and products);
13. condiments;
14. fish and seafood;
15. to the food in direct contact with food placement and material substances and preparations;
16. agents and safe ingredients like food supplies;
17. food sweeteners;
18. fruit and fruit products;
19. gelatin, milk enzymes, puddings and fillings;
20. ice cream and related food products;
21. imitation dairy products;
22. pasta and noodles;
23. meat, meat and poultry products;
24. milk, butter and dried milk products;
25. dinner foods and gravies, sauces and specialty products;
26. dried fruit and nuts;
27. shell eggs and egg products;
28. dessert (flour, meat and vegetables);
29. pepper, salt, chemicals and special flavor;
30. Soups;
31. soft drinks and bottled water;
32. vegetables and vegetable products;
33. vegetable oil (including olive oil);
34. vegetable protein products (meat side);
35. whole grains and flour processed foods, starch, etc.;
36. or all of the main products for human consumption;
FDA approved medical devices
FDA management for medical devices and radiological health centers through the instrument (CDRH) conducted by the Centre supervise the production of medical devices, packaging, dealers comply with the law under the business activities.
A wide range of medical devices, small medical gloves, ranging from pacemakers, are under the supervision of the FDA, based on medical uses and possible injury to humans, FDA medical device will be divided into Ⅰ, Ⅱ, Ⅲ class, the higher Category supervise more.
If the product is on the market did not exist novel invention, FDA requires manufacturers to conduct rigorous human trials, and there is a compelling medical and statistical evidence of the product's effectiveness and safety.
FDA approval of medical devices, including: manufacturers in FDA registered, FDA product registration, product listing registration (510 enrollees), market review and approval (PMA review) health care equipment labels and technological innovation, customs clearance, registration, prior to listing report, shall submit the following materials:
(A) finished products packaged complete in five copies,
(2) Device structure diagram and text description
(3) the performance of equipment and working principle;
(4) device safety demonstration or testing materials,
(5) Manufacturing Process Description,
(6) clinical trial summary
(7) product specifications, such as the equipment or release of radioactive radioactive material can be described in detail.
Medical equipment factories and product registration
FDA for medical devices are clear and strict definition, which is defined as follows: "The so-called medical equipment is subject to the following conditions of the instrument, apparatus, tools, machinery, equipment, insertion tube, in vitro reagent, and other related items, including components, parts, or Accessories: explicitly listed in the National Formulary, or the Unite States Pharmacopeia or the aforesaid two appendices are; expected to be used in animal or human disease, or other physical conditions diagnosed, or for disease cure, mitigation and treatment; expected impact animal or human body function or structure, but not via metabolism to achieve its main objective person. "
Only products that meet the above definition of party is regarded as medical devices, in this definition, not only in hospitals of various instruments and tools, even if consumers can buy at the general store of spectacle frames, glasses, toothbrushes and other fitness equipment and massage belong to the scope of the FDA management. It finds domestic medical devices is slightly different.
According to the different levels of risk, FDA medical device will be divided into three categories (Ⅰ, Ⅱ, Ⅲ), Ⅲ class highest level of risk. Each medical device FDA will have to clearly define their product classification and management requirements of the current FDA medical device product catalog Total 1,700 kinds. Any kind of medical device you want to enter the U.S. market, we must first understand the application for listing products classification and management requirements.
FDA for medical devices developed a number of bills from time to time to modify and supplement, but the underlying bill is not much, including: the Federal Food, Drug, and Cosmetic Act (FD & C Act, the fundamental Act); Public Health Service Act; just packaging and identification bill; Radiation Control for Health and Safety Act; Safe Medical Devices Act; Modernization Act. These bills, FDA gave a very detailed explanation and supporting a specific operating requirements. Companies plan to enter the U.S. market before the need to carefully evaluate products for their own specific regulations and requirements related (including different American product standards).
After the above information in a clear, companies can begin preparing for the disclosure of information in accordance with certain procedures reported to the FDA to obtain approval of recognition. For any product, companies are required to carry out business registration (Registration) and the product column names (Listing). Right Ⅰ products (accounting for about 47%), the implementation of the general control (General Control), most of the products simply to register the column names and implementation of GMP standards, the products to enter the U.S. market (which is also rare product GMP exemption, a handful of products you need to keep submitting to FDA 510 (K) application that PMN (Premarket Notification)); class Ⅱ products (accounting for about 46%), the implementation of the special control (Special Control), enterprises in the registration and column names, the need to implement GMP and submit 510 (K) application (rare product is 510 (K) exemption); pair Ⅲ products (about 7%), the implementation of a Premarket Approval, enterprises in the registration and column names, shall submit the implementation of GMP to FDA PMA (Premarket Application) Application (Part Ⅲ products or PMN).
For class Ⅰ products, companies submit relevant information to the FDA, FDA only make an announcement, there is no relevant documents distributed enterprise; right Ⅱ, Ⅲ class equipment, the enterprise must submit a PMN or PMA, FDA, while in the announcement, will give enterprises formal market access approval letter (Clearance), which allows companies in their own name in the U.S. medical device market to sell their products directly. As to whether the application process to the corporate on-site GMP assessment, risk level according to the product by the FDA, regulatory requirements and market feedback and other comprehensive factors.
Based on the above content shows that most of the products during the business registration, product listing and implementation of GMP, or re-submit a 510 (K) application, you can get FDA clearance to market.
1.510 (K) file that is FDA files needed for PMN, because the corresponding FD & C Act section 510, it is usually called 510 (K) file.
2. Substantive equality comparisons (SE)
3.510 (K) review process
Prior to the application must be clear whether the product is recognized by the FDA as a medical device, product category, management requirements, apply clear job content;
Check the products listed on the application whether the U.S. mandatory standards, whether the products meet the standard (general requirements for the official testing organizations test report);
In preparation 510 (K) application documents before the need to consider whether it really needs to submit, submit and when to submit the nature of which 510 (K) Application: General 510 (K), Special 510 (K), to simplify 510 (K) ;
FDA on the application process issues raised should be promptly given in writing, timely answer;
All information submitted to the FDA should use the paper size Letter Size (21.5cm X 29.7cm);
All companies need to submit data from the FDA left backup because the FDA after receipt of the application data electronically scanned login, and the destruction of application information and does not return business.
On a small number of products, FDA will conduct on-site GMP enterprise assessment, companies need to refer to the United States GMP management requirements, and the FDA site audit with the right of GMP and enterprises have a certain understanding of the translators;
Required to inform the FDA's formal contacts and working procedures of the FDA regulations have a certain understanding, and can communicate directly with the FDA to facilitate timely feedback, businesses can clear themselves or entrust advisory body responsible for daily communication with the FDA.
Cosmetics FDA certification
Cosmetics Voluntary Registration Scheme (VCRP)
FDA Office of Cosmetics and pigmented cosmetic industry should be required to develop a voluntary registration scheme for cosmetics. Plan includes two parts: the cosmetics manufacturers and cosmetic ingredients voluntary registration statement.
Benefits of participating VCRP
Manufacturers voluntarily register and receive a registration number does not mean that FDA approval of the manufacturer or its products, FDA does not allow manufacturers to use participatory VCRP or obtain the registration number or column name for commercial promotion; but manufacturers can be directly obtained by participating in the following VCRP Benefits:
Important information for cosmetic ingredients. FDA will VCRP get all the information entered into the computer database. If you are using some kind of cosmetic ingredients once they are considered to be harmful and should be banned, FDA through VCRP notification contacts database product manufacturer or distributor. If your product is not in the registration database, FDA will not be able to inform you.
Avoid problems caused ingredients imported products being recalled or detained. If cosmetics manufacturers to product formulations in VCRP record, as long as the FDA found that manufacturers use in formulations unapproved color additives or other banned ingredients, will remind manufacturers attention. In this way, manufacturers can import or sale of the product before modifying product formulations, thereby eliminating the use of lead because of improper ingredient product being recalled or detained risk. Help retailers identify safety-conscious manufacturers. Retailers (such as department stores) sometimes asked whether FDA a cosmetics company registered with the FDA. Although registration does not mean that FDA approval, but it shows that your product through the FDA review and enter the government's database. If you submit product formulations incomplete, or contain some banned ingredients or unapproved color additives, FDA will notify you.
The decision was based on samples collected nature of the products; FDA priority concerns; product of past history. FDA to obtain a physical sample and send it to the laboratory for analysis FDA District
If the FDA found that the sample meets the requirements, respectively, to the U.S. Customs and importers to send a "release notice."
If the FDA concluded that the sample "a violation of FDCA performance and other relevant laws," respectively, and the case to the U.S. Customs and importers Send "seizure and notice of hearing." Notice of violation and the nature and details to the case and the importer 10 days to provide evidence that the goods may be permitted.
Imported goods have been seized by the FDA or the United States must be under the supervision of Customs trimmed reinfusion or destroyed
Hearing is the importer for the import of defense articles or provide evidence to the goods after trimmed the only opportunity for immigrants.
If the case and underwriters, the owner, importer, or a designated representative of the non-response letter, FDA and the case to the U.S. Customs and importers Send "refused permission to notice." Then issue the reach of product transfusion or destroyed.
If the case and underwriters, the owner, importer, or a designated representative replied "seizure and notice of hearing," When the importer to provide evidence that the product "meets expectations" or submitting an application when finishing products, FDA had seized products hearing.
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