FDA approval

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The Food and Drug Administration (FDA) is one of the executive agencies established by the United States government within the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS). As a scientific regulatory agency, FDA is responsible for ensuring the safety of foods, cosmetics, drugs, biologics, medical devices, and radiological products manufactured or imported into the United States. It was one of the first federal agencies to have consumer protection as its primary function.

Detailed introduction

This institution touches the lives of every American citizen. Internationally, FDA is recognized as one of the largest food and drug regulatory agencies in the world. Many other countries promote and monitor the safety of their products by seeking and receiving FDA assistance.

The Director of the Food and Drug Administration (FDA) : supervision and inspection of foods, drugs (including veterinary drugs), medical devices, food additives, cosmetics, animal foods and drugs, wine beverages with an alcohol content of less than 7%, and electronic products; It also includes cosmetics, radiation products, combination products and other electronic products and medical products related to personal health and safety. Testing, inspection and certification of ionic and non-ionic radiation produced during the use or consumption of products affecting human health and safety. According to the regulations, the above products must be tested by the FDA to prove safe before they can be sold on the market. The FDA has the power to inspect manufacturers and prosecute violators. According to the different product range regulated, it can be divided into the following main regulatory bodies:

1. Center for Food Safety and Practical Nutrition (CFSAN):

The center has the largest workload at the FDA. It is responsible for food safety throughout the United States except for meat, poultry and eggs, which are regulated by the United States Department of Agriculture. Although the United States has one of the safest food supplies in the world, about 76 million foodborne illnesses occur each year, 325,000 people need to be hospitalized for foodborne illnesses, and about 5,000 people die from foodborne illnesses. The Center for Food Safety and Nutrition works to reduce foodborne illness and promote food safety. And promote various programs, such as: HACCP program promotion and implementation.

The functions of the Centre include: ensuring the safety of substances and pigments added to food; Ensuring the safety of foods and ingredients developed through bioprocesses; Responsible for the management of the correct labelling of food products (e.g. ingredients, nutritional health claims) and cosmetics; Develop policies and regulations governing dietary supplements, infant food formulations and medical foods; Ensure the safety of cosmetic ingredients and products and ensure proper labeling; Supervise and regulate the after-sale behavior of the food industry; Conduct consumer education and behavior development; Cooperative projects with state and local governments; Coordinate international food standards and safety, etc.

2. Center for Drug Evaluation and Research (CDER):

The center aims to ensure the safety and effectiveness of prescription and over-the-counter drugs, evaluate new drugs before they are marketed, and monitor more than 10,000 drugs on the market to ensure that products meet the highest standards, which are constantly updated. The center also monitors the authenticity of advertisements for drugs on television, radio and in print. Strictly monitor drugs and provide consumers with accurate and safe information.

3, Equipment Safety and Radiation Protection Health Center (CDRH):

The center ensures the safety and effectiveness of newly marketed medical devices. That's because more than 20,000 companies around the world make more than 80,000 medical devices of all types, from blood sugar monitors to artificial heart valves. These products are closely related to people's lives, so the center also oversees after-sales service across the country. The center has also established safety standards for products that produce radiation, such as microwave ovens, television sets and mobile phones.

4. Center for Biologics Evaluation and Research (CBER):

The center oversees biologics that prevent and treat disease, and is therefore more complex than chemical-complex drugs, including scientific research into the safety and effectiveness of blood, plasma, vaccines and more.

5. Veterinary Drug Center (CVM):

FDA Certification Introduction

FDA food certification

FDA's regulatory agency for food, agricultural products, and seafood is the Center for Food Safety and Nutrition (CFASAN), whose responsibility is to ensure that the food supply for Americans is safe, clean, fresh, and clearly labeled.

The CFS monitors US $240 billion in food imports annually, of which US $15 billion is imported food. The CFS main monitoring priorities include:

1. Food freshness;

2, food additives;

3. Food biotoxins and other harmful ingredients;

4. Seafood safety analysis;

5, food identification;

6. Tracking and warning of food after listing

Under the anti-terrorism law passed by the U.S. Congress in 2003, food companies outside the United States must register with the FDA before exporting to the United States and notify the FDA of shipment at the time of export.

The following foreign food production and processing enterprises are required to register with the FDA under U.S. Public Law 107-188:

1. Alcohol and alcoholic beverages;

2. Baby and child food;

3. Bread and pastries;

4. Drink;

5. Candy (including chewing gum);

6. Cereals and ready-to-eat cereals;

7. Cheese and cheese products;

8, chocolate and cocoa food;

9. Coffee and tea products;

10, food coloring;

11, weight loss conventional food and medicinal food, meat substitutes;

12, supplementary food (i.e. domestic health food, vitamins and Chinese herbal products);

13. Condiments;

14. Fish and seafood;

15. Materials and products placed into food and in direct contact with food;

16, food additives and safe ingredients of food supplies;

17, food sugar substitute;

18. Fruits and fruit products;

19, edible glue, milk enzyme, pudding and filling;

20, ice cream and related food;

21, imitation milk products;

22. Macaroni and noodles;

23. Meat, meat products and poultry products;

24. Milk, butter and dry dairy products;

25, dinner food and marinades, sauces and specialty products;

26, dried fruits and nuts;

27. Eggs and egg products in shell;

28, snacks (flour, meat and vegetables);

29, pepper, special taste and salt;

30. Soup;

31. Soft drinks and canned water;

32. Vegetables and vegetable products;

33. Vegetable oil (including olive oil);

34, vegetable protein products (square meat food);

35, whole grain food and flour processing food, starch, etc.;

36. Products primarily or wholly intended for human consumption;

FDA Medical Certification

FDA regulates medical devices through the Center for Devices and Radiological Health (CDRH), which monitors the manufacturing, packaging, and distribution of medical devices in compliance with the law.

A wide range of medical devices, as small as medical gloves, as large as cardiac pacemaker, are under FDA supervision, according to medical use and possible harm to the human body, FDA medical devices are divided into Ⅰ, Ⅱ, III classes, the higher the category supervision more. If the product is a novel invention that does not exist on the market, the FDA requires that the manufacturer conduct rigorous human testing and that there is compelling medical and statistical evidence of the product's effectiveness and safety.

FDA certification of medical devices, including: manufacturer registration in FDA, FDA registration of products, product listing registration (510 form registration), product listing review and approval (PMA audit) of medical devices label and technical transformation, customs clearance, registration, pre-market report, must submit the following materials: (1) Package five complete finished products, (2) structure diagram and text description of the device, (3) performance and working principle of the device; (4) Safety demonstration or test materials of the device, (5) introduction to the manufacturing process, (6) summary of clinical trials, (7) product description. If the device has radioactive energy or releases radioactive material, it must be described in detail.

FDA Cosmetic Certification

Voluntary Registration Scheme for Cosmetics (VCRP)

FDA's Office of Cosmetics and Colorants has developed a voluntary registration program for cosmetics at the request of the cosmetics industry. The scheme consists of two parts: voluntary registration of cosmetic manufacturers and declaration of cosmetic ingredients.

Benefits of participating in VCRP

A manufacturer's voluntary registration and obtaining a registration number does not indicate FDA's approval of the manufacturer or its products, nor does FDA permit manufacturers to use the registration number or listing number obtained by participating in VCRP or for commercial promotion; However, manufacturers can directly gain the following benefits by participating in VCRP:

Get important information about cosmetic ingredients. The FDA enters all the information it receives from the VCRP into a computer database. If a cosmetic ingredient currently in use is deemed to be harmful and should be banned, FDA notifies the manufacturer or seller of the product via an address book in the VCRP database. If your product is not in the registry database, the FDA will not be able to notify you.

Avoid being detained when products are recalled or imported due to ingredients. If a cosmetic manufacturer files a formula with the VCRP, the FDA will alert the manufacturer if it finds that the manufacturer has used an unapproved color additive or other prohibited ingredient in the formula. This allows manufacturers to modify product formulations before they are imported or sold, eliminating the risk of product recalls or seizures due to improper ingredient use. Help retailers identify safety-conscious manufacturers. Retailers (such as department stores) sometimes ask the FDA if a cosmetics company is registered with the FDA. Although registration does not mean FDA approval, it does indicate that your product has been reviewed by the FDA and entered the government database. If your submitted product formulation is incomplete or contains a prohibited ingredient or unapproved color additive, the FDA will notify you.

The decision to collect samples is based on the nature of the product; FDA priority concerns; History of the product. FDA obtains a physical sample and sends it to an FDA regional laboratory for analysis

If the FDA finds that the sample meets the requirements, it sends a separate "release notice"; to U.S. Customs and the importer.

If the FDA determines that the sample is "in violation of FDCA and other relevant laws," it sends a "Notice of Seizure and Hearing" to U.S. Customs and the importer, respectively. The notice details the nature and nature of the offence and gives the case and the importer 10 working days to provide evidence that the goods are permitted.

Impounded imports must be repaired, returned, or destroyed under the supervision of FDA or U.S. Customs

The hearing is the only opportunity for the importer to defend the imported goods or provide evidence that will make the goods fit for entry after being repaired.

If the case and the underwriter, shipper, importer, or a designated representative do not respond to the notification, FDA sends a "Denial notice" to U.S. Customs and the case and importer. The product in question is then returned or destroyed.

If the case and the underwriter, shipper, importer, or a designated representative respond to the Notice of Seizure and Hearing, FDA holds a hearing on the seized product when the importer provides evidence that the product "meets requirements"; or submits a petition to fix the product.

If the company provides evidence that the product meets the requirements, FDA will take follow-up samples. After analysis, the product is either released or denied entry.

FDA reviews the importer's proposed modification procedures and either approves or disapproves them as appropriate. Once approved, FDA will conduct follow-up testing/sample collection to determine eligibility. If the sample is acceptable, send a "release notice"; to U.S. Customs and the importer. If the sample is not qualified, the "rejection notice"; will be issued.

Section 8 (C) of the FDCA requires the applicant to pay the full cost, including travel, daily use, and wages of FDA officers or employees, in addition to the cost of updating the label or other measures to bring the seized goods into compliance with the provisions of the Application (FDA-766 Form). By submitting Form FDA-766, the applicant agrees to pay the full regulatory fee under current regulations.

FDA drug approval

The FDA has a comprehensive certification process for pharmaceutical products to ensure that new drugs are safe and effective. The procedure is as follows:

1. Investigational New Drug Application (IND):

When a pharmaceutical company submits an IND to the FDA, the FDA's monitoring of the new drug begins. At this time, human trials of new drugs have not yet begun, and the FDA mainly reviews in vitro safety data and animal experimental data to determine whether the drug is safe enough to enter the human trial stage.

2. Human experiments:

There are four stages in the human experiment. The first phase mainly tests the safety of drugs, main side effects, metabolic mechanism, etc., and the sample number is generally less than today.

Phase II tests the effectiveness of the drug to determine whether it can effectively act on the human body. At the same time, the safety and side effects of drugs are also the object of close observation. The sample size of Phase II experiments is generally less than 300.

If Phase II is encouraging, a larger sample will be ready for testing, and the experiment will move to phase III. Phase III will include different age groups, different populations, and different doses of the drug to comprehensively study the safety and effectiveness of the drug. The sample size of the phase III experiments ranged from several hundred to several thousand.

Phase IV is mainly conducted after the approval of a new drug and mainly tests the long-term safety of the drug, new populations, etc.

3. New Drug Application (NDA):

When the pharmaceutical company has completed human trials to verify the safety and effectiveness of the new drug, it formally submits an NDA application to the FDA. FDA reviews all animal and human experimental data, as well as drug digestion mechanism data, GMP data for drug production, if the data is incomplete or unreasonable, FDA will refuse to review, otherwise FDA will complete the review in about 10 months, and give an agreement or rejection.

The above content is extracted from the MTG FDA Certification Service Center Service Manual.

FDA Certification Process

1. Preparation

Copy of enterprise legal person license;

Production (health) license, copy of certificate;

Company profile (established time, technical strength, main products and performance, asset status).

2. Acceptance of technical preliminary examination declaration

Submit the English translation of DMF (Drug Master File) and SOP (Standard Operating Procedure) to the agent;

According to the comments of the agent, the above documents shall be modified.

3. DMF data review

FDA carefully reviewed and visited the factory site to check whether the DMF documents were true;

If FDA finds no significant errors and determines that the requirements are met, a pre-approval inspection plan is proposed.

4. FDA inspection

FDA inspectors inspect the plant, ask questions, and the plant must answer each one;

If in doubt, the official will give a ";483"; form (rectification proposal), serious problems, do not give a ";483"; form.

5. FDA issues ";Approval Letter";

The questions raised by the prosecutor on the "483"; must be answered carefully, and if there is a problem, it must be corrected and proven immediately;

Questions that the prosecutor does not understand need to be explained

FDA material certification

Food contact materials refer to all materials that can come into contact with food during processing, production, packaging, storage and transportation of food. Common materials include a variety of plastic metal ceramic glass bamboo and wood products, these and food can be exposed to the environmental safety of the material directly related to the user's dietary safety and health, so the export of such products to the United States in accordance with FDA standards for relevant testing and certification

Common FDA certification testing items for food contact materials are as follows:

Organic coated, metal, and electroplated articles require U.S. FDA CFR 21 175.300.

water extractives deionized water leaching method

8% alcohol extractives. 8% alcohol extractives

n-heptane extractives process

Paper products require U.S. FDA CFR 21 176.170

Net chloroform soluble extractives for water fraction. Net chloroform soluble extractives for water fraction.

Net chloroform soluble extractives for 8% alcohol fraction Net chloroform soluble extractives for 8% alcohol fraction

Net chloroform soluble extractives for 50% alcohol fraction Net chloroform soluble extractives for 50% alcohol fraction

Net chloroform soluble extractives for n-heptane fraction Net chloroform soluble extractives for n- Heptane fraction

Lumber required U.S. FDA CFR 21 178.3800

Pentachlorophenol and its salt PCP

ABS requires U.S. FDA CFR 21 181.32 or 180.22.

Deionized water leaching method in water

in 3% acetic acid. In 3% acetic acid

Leach in 8% ethanol. In 8% ethanol

Leaching in n-heptane

FDA Laser Certification

1. Application Form

Application form: contains company information, product information, etc

2. Product File / Technology Specification

Product documents/technical documents: mainly includes preparing detailed manual/sales manual, installation manual, maintenance manual, etc. Product assembly drawing; As well as product technical information, whether there are laser protection measures and a description of the working principle.

3. Label

Labels: compliant English labels, warning labels with warning marks, product labels, compliance certification labels (e.g., Complies with 21 CFR 1040.10 & 1040.11), and outlet labeling labels, etc.

4. Laser Information

Laser device information: type of laser generator, medium, laser optical diagram, laser parameters, laser device certificate/test record (if purchased from other manufacturers, need to provide the manufacturer's information, laser device parameters /Datasheet or manual, and the laser device has FDA certification/FDA number if there is).

5. Calibration Report of Power Meter

Optical power meter annual metrological verification certificate and report.

6. Quality Control System

Quality control documents: mainly include internal quality control flow chart, inspection procedures, quality control specifications/such as design modification control; Production line sampling table, incoming material test sheet, finished product test sheet, internal inspection report, etc. (including the sample of the table).

7. US Agent / Importer

Us agent and US importer information: including full name of contact person, telephone/fax/email, US address/postal code, company name; And U.S. Agent Principal Agent licensing agreement.

     FDA certification application process

Enterprise registration

Application form for business registration

FDA confirms and issues enterprise serial numbers; 1.2. Product registration

1 Medical device products are divided into 3 categories according to the degree of safety risk: a) Category 1 medical device listing control

Type 2 market access approval (i.e. 510 (K) approval) c) Type 3 PMA pre-market approval 1.2.2 Proxy

FDA Registration and Notification Entrustment Agreement (signed by the legal representative and stamped with the company's official seal) 1.2.3 Provide information

Business license of enterprise legal person

Business legal person code certificate, registration certificate of association legal person, etc. (Photocopy stamped with company seal) c) Qualification certificate or production license certificate within the validity period (photocopy stamped with company seal) d) FDA Registration Application Form (one in Chinese and one in English stamped with company seal) e) Other documents newly added by FDA (if any).

Enterprise profile (enterprise establishment time, economic performance, technical strength, main production varieties and their performance, asset status). 1.3 Payment

Registration and listing are free;

The 510(K) and PMA are subject to the fees published online by FDA.

register

Fee calculation, FDA60 working days to complete registration;

The FDA website informs the registration status, and the FDA sends a separate approval letter for 510(K) and PMA

FDA certification free consultation telephone: 0755-27753399 19925332787