The main four categories of products registered with the US FDA

release time :2024-03-27 14:48:54    

The FDA's regulatory agency for food, agricultural products, and seafood is the Center for Food Safety and Nutrition (CFASAN), which is responsible for ensuring that American food supply is safe, clean, fresh, and clearly labeled.

In our daily trade and daily life, we mainly deal with products that require FDA certification, including the following four major products:

1、 Food

The FDA Center supervises food imports of $240 billion annually, of which $15 billion is imported food. The Center's main monitoring focuses include:

1. Freshness of food; 2. Food additives; 3. Other harmful components of food biotoxins; 4. Seafood safety analysis; 5. Food labeling; 6. Tracking and warning after food is launched

According to the anti-terrorism law passed by the United States Congress in 2003, food companies outside the United States must register with the FDA before exporting to the United States and provide shipping notifications to the FDA at the time of export

Foreign food production and processing enterprises that are required to register with the FDA under US Public Law 107-188 are as follows:

1. Alcohol and alcoholic beverages; 2. Infant and children's food; 3. Bread and pastry category; 4. Beverages; 5. Candy (including chewing gum); 6. Cereals and ready to eat cereals;

7. Cheese and cheese products; 8. Chocolate and cocoa based foods; 9. Coffee and tea products; 10. Food colorants; 11. Regular weight loss foods, medicinal foods, and meat substitutes;

12. Supplementary foods (including domestic health foods, vitamin drugs, and traditional Chinese herbal products); 13. Seasonings; 14. Fish and seafood; 15. Placing materials, substances, and products that come into direct contact with food; 16. Food additives and safe ingredients for food products; 17. Food sweeteners; 18. Fruits and fruit products;

19. Edible glue, lactase, pudding, and filling; 20. Ice cream and related foods; 21. Imitation dairy products; 22. Macaroni and noodles; 23. Meat, meat products, and poultry products; 24. Milk, butter, and dry dairy products; 25. Dinner food and sauces, sauces, and specialty products;

26. Dried fruits and kernels; 27. Shelled eggs and egg products; 28. Dim sum (flour, meat and vegetables); 29. Chili peppers, specialty foods, 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 products); 35. Whole wheat food and flour processed foods, starch, etc;

36. Products primarily or entirely intended for human consumption

2、 Medical devices

The FDA manages medical devices through the Centers for Devices and Radiological Health (CDRH), which oversees the production, packaging, and distribution of medical devices in compliance with legal regulations.

The range of medical devices is very wide, ranging from medical gloves to cardiac pacemakers, all of which are under FDA supervision. Based on their medical use and potential harm to the human body, the FDA classifies medical devices into categories I, II, and III, with higher categories providing more supervision

If the product is a novel invention that has never existed in the market, the FDA requires manufacturers to conduct rigorous human experiments and have convincing medical and statistical evidence to demonstrate the effectiveness and safety of the product.

The FDA certification for medical devices includes: manufacturer registration with FDA, product registration with FDA, product listing registration (510 form registration), product listing review approval (PMA review), labeling and technical modification, customs clearance, registration, and pre marketing report for healthcare devices. The following materials must be submitted: (1) five complete packaged finished products, (2) device construction drawings and their textual explanations, (3) device performance and working principles; (4) Safety demonstration or test materials for the device, (5) Introduction to manufacturing process, (6) Summary of clinical trials, (7) Product manual If the device has radioactive properties or releases radioactive substances, it must be described in detail

Factory and product registration of medical devices

The FDA has a clear and strict definition of medical devices, which is as follows: "Medical devices refer to instruments, devices, tools, machinery, instruments, insertion tubes, in vitro reagents, and other related items that meet the following conditions, including components, parts, or accessories: those explicitly listed in the National Formula or the United States Pharmacopeia or their appendices; those expected to be used for the diagnosis of animal or human diseases or other physical conditions, or for the cure, mitigation, and treatment of diseases; those expected to affect the function or structure of animal or human bodies, but not through metabolism to achieve their main purpose.".

Only products that meet the above definition are considered medical devices. Under this definition, not only various instruments and tools in hospitals, but also fitness equipment such as eyeglass frames, glasses, toothbrushes, and massagers that consumers can purchase in general stores, are within the scope of FDA management. It is slightly different from the recognition of medical devices in China.

According to different risk levels, the FDA classifies medical devices into three categories (I, II, III), with Class III having the highest risk level. The FDA has clearly defined the product classification and management requirements for each medical device, and there are over 1700 types in the FDA medical device product catalog. Any medical device that wants to enter the US market must first clarify the product classification and management requirements for application for market launch.

The FDA has formulated many laws for medical devices, which are amended and supplemented from time to time, but there are not many fundamental laws, mainly including the Federal Food, Drug, and Cosmetic Act (FD&C Act); The Public Health Services Act; Fair Packaging and Labeling Act; Health and Safety Radiation Control Act; The Safety Medical Device Act; Modernization Act. The FDA has provided very detailed explanations and specific operational requirements for these bills. Before planning to enter the US market, enterprises need to carefully evaluate the regulations and specific requirements related to their products (including different US product standard requirements).

After clarifying the above information, enterprises can start preparing relevant application materials and follow certain procedures to apply to the FDA for approval and recognition. For any product, enterprises need to register and list products. For Class I products (accounting for about 47%), General Control is implemented, and the vast majority of products only need to register, list, and implement GMP standards to enter the US market (with a very small number of products even exempted from GMP, and a very small number of retained products requiring a 510 (K) application or PMN (Premarket Notification) to be submitted to the FDA); For Class II products (accounting for about 46%), special control is implemented. After registration and listing, enterprises also need to implement GMP and submit 510 (K) applications (very few products are exempt from 510 (K)); For Class III products (accounting for about 7%), pre market licensing is implemented. After registration and listing, enterprises must implement GMP and submit a PMA (Pre Market Application) application to the FDA (some Class III products are still PMN).

For Class I products, after the enterprise submits relevant information to the FDA, the FDA only makes announcements and does not issue relevant documents to the enterprise; For Class II and III devices, companies must submit a PMN or PMA. At the same time as the announcement, the FDA will provide the company with a formal market access approval letter (Clearance), allowing the company to directly sell its products in its own name in the US medical device market. As for whether to conduct on-site GMP assessment at the enterprise during the application process, it is determined by the FDA based on comprehensive factors such as product risk level, management requirements, and market feedback.

Based on the above content, it can be concluded that the vast majority of products can obtain FDA approval for listing after enterprise registration, product listing, and implementation of GMP, or after submitting a 510 (K) application.

The 1.510 (K) file, also known as the file required by the FDA for PMN, is commonly referred to as the 510 (K) file due to its corresponding FD&C Act Chapter 510.

2. Comparison of substantive equality (SE)

3.510 (K) Review Procedure

Before applying, it is necessary to clarify whether the product is recognized by the FDA as a medical device, the product category, management requirements, and the scope of the application work;

Check whether there are mandatory US standards for products applying for listing, and whether the products comply with these standards (usually requiring formal inspection reports from testing institutions);

Before preparing the 510 (K) application documents, it is necessary to consider whether it is truly necessary to submit, when to submit, and what type of 510 (K) application to submit: regular 510 (K), special 510 (K), simplified 510 (K);

Provide timely written and timely answers to the questions raised by the FDA during the application process;

All documents submitted to the FDA should use Letter Size (21.5cm X 29.7cm) for paper size;

All companies submitting materials to the FDA must keep a backup, as the FDA electronically scans and logs in the application materials upon receipt, destroys them, and does not return them to the company.

For a small number of products, the FDA will conduct on-site GMP assessments on enterprises. Enterprises need to refer to the US GMP management requirements and be equipped with appropriate translators who have a certain understanding of GMP and the enterprise during on-site FDA audits;

Inform the official contact person of the FDA that they need to have a certain understanding of FDA regulations and work procedures, and be able to communicate directly with the FDA for timely feedback. Enterprises can clarify their own or entrust consulting agencies to be responsible for daily communication with the FDA.

3、 Cosmetics

FDA registration certification

Voluntary Cosmetic Registration Program (VCRP)

The FDA Cosmetics and Colorants Office has developed a voluntary registration plan for cosmetics in response to the requirements of the cosmetics industry. The plan includes two parts: voluntary registration of cosmetic manufacturers and declaration of cosmetic ingredients.

The benefits of participating in VCRP

The voluntary registration and acquisition of a registration number by a manufacturer does not imply FDA approval of the manufacturer or its products, and FDA does not allow manufacturers to use the registration or listing numbers obtained through participation in VCRP for commercial promotion; But manufacturers can directly benefit from participating in VCRP by:

Obtain important information on cosmetic ingredients. The FDA will input all information obtained from VCRP into a computer database. If a cosmetic ingredient currently used is deemed harmful and should be banned, the FDA will notify the manufacturer or seller of the product through the contact list in the VCRP database. If your product is not registered in the database, the FDA will not be able to notify you.

To avoid product recall or detention during import due to ingredient issues. If cosmetic manufacturers file their product formulas with VCRP, the FDA will remind them to pay attention if they find that the manufacturer has used unapproved pigment additives or other prohibited ingredients in the formula. In this way, manufacturers can modify the product formula before importing or selling it, thereby eliminating the risk of product recall or detention due to improper use of ingredients. Assist retailers in identifying safety conscious manufacturers. Retailers (such as department stores) sometimes ask the FDA if a cosmetics company has been registered with the FDA. Although registration does not indicate FDA approval, it indicates that your product has been reviewed by FDA and entered into government databases. If the product formula you submit is incomplete, or contains certain prohibited ingredients or unapproved color additives, the FDA will notify you.

The decision to collect samples is based on the nature of the product; FDA's key focus issues; The past history of the product. FDA obtains a physical sample and sends it to the FDA regional laboratory for analysis

If the FDA finds that the sample meets the requirements, it will send a release notice to both the US Customs and the importer.

If the FDA determines that the sample has "shown signs of violating FDCA and other relevant laws," it shall send "detention and hearing notices" to US Customs, the case, and the importer respectively. The notice shall provide a detailed explanation of the illegality and nature, and shall give the case and importer 10 working days to provide evidence that the batch of goods can be allowed.

Imported goods that have been seized must be repaired, returned, or destroyed under the supervision of the FDA or US Customs

A hearing is the only opportunity for importers to defend imported goods or provide evidence that can make the goods suitable for entry after being repaired.

If the underwriter, consignor, importer, or designated representative of the case does not respond to the notice, the FDA will send a "refusal notice" to US Customs and the case and importer. Then the products involved in the problem are returned or destroyed.

If the case involves underwriters, shippers, importers, or a designated representative responding to the "Notice of Seizure and Hearing", the FDA will hold a hearing on the seized product when the importer provides evidence that the product "meets the requirements" or submits an application to modify the product.

If the business provides evidence that the product meets the requirements, the FDA will collect subsequent samples. After analysis, it will be decided whether the product will be released or denied entry.

The FDA reviews the proposed amendment procedures of importers and may approve or disapprove them depending on the situation. Once approved, the FDA will conduct subsequent inspections/sample collection to determine its eligibility. If the sample is qualified, send a "release notice" to the US customs and importer. If the fruit sample is found to be unqualified, a rejection notice will be issued.

Section 8 (C) of the FDCA requires the applicant to pay all expenses, including travel, daily expenses, and wages of FDA officials or employees, in addition to updating labels or other measures to comply with the terms of the application (FDA-766 Form) for seized goods. By submitting the FDA-766 form, the applicant agrees to pay all regulatory fees in accordance with current regulations.

4、 Medicines

FDA registration certification

The FDA has a complete certification process for pharmaceutical products to ensure the safety and effectiveness of new drugs. The process is as follows:

1. Investigative New Drug Approval (IND):

When pharmaceutical companies submit INDs to the FDA, FDA monitoring of new drugs begins. At this time, human trials of the new drug have not yet begun, and the FDA mainly reviews in vitro safety data and animal trial data to determine whether the drug is safe enough to enter the human trial stage

2. Human experiments:

The human experiment is divided into four stages The first phase mainly tests the safety, main side effects, metabolic mechanisms, etc. of drugs, and the sample size is generally less than 200

The second phase mainly tests the effectiveness of drugs to determine whether they can effectively act on the human body Meanwhile, the safety and toxic side effects of drugs are also closely monitored The sample size for the second phase experiment is generally less than 300

If the second phase experiment is encouraging, a larger sample will be prepared for testing, and the experiment will enter the third phase The third phase will include different age groups, populations, and dosages to comprehensively study the safety and efficacy of drugs The sample size of the third phase experiment ranges from a few hundred to several thousand

The fourth phase is mainly conducted after the approval of new drugs, mainly testing the long-term safety of drugs, new populations, etc

3. New Drug Application (NDA):

After completing human experiments and verifying the safety and efficacy of the new drug, the pharmaceutical company officially submitted an NDA application to the FDA The FDA reviews all animal and human experimental data, as well as data on drug delivery mechanisms and GMP data for drug production. If the data is incomplete or unreasonable, the FDA will refuse to apply. Otherwise, the FDA will complete the application within about 10 months and provide approval or rejection opinions

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