How long does it take for the U.S. FDA to register

The registration process and cycle are different for different products, and the following are examples of several types of products that are commonly exported.

FDA food enterprise registration process: for ordinary food, provide the company's English information, product category, contact information, submit to FDA to obtain the registration number, enterprise registration time is 1-3 working days. For canned sealed packaged food, in addition to FDA registration, it is also necessary to apply for FCESID sealed canned food registration and product process declaration, which needs to be submitted to the FDA for review and SID number before being exported to the United States, with a cycle of 1-2 months.

For 510K exempted products (most of them are Class I products, a small number of Class II products), submit the company's English information, product proprietary name, and importer information, and submit it to the FDA to obtain the registration number. After the registration is completed, the first to get the owner number and device listing number can be exported to the United States for customs clearance, and the registration number needs 90 days FDA manual allocation. For products that must have 510K or PMA certification (a small number of Class I products, most Class II products and Class III products), companies need to compare similar products that have been marketed, provide relevant tests, and even clinical data to obtain FDA 510K number or PMA number before they can register with FDA.

The registration cycle for products that do not require 510k is 5-7 working days, and the registration cycle for products that require 510k is at least 6 months.

The FDA drug company registration process requires the provision of enterprise information, DUNS number, product label, etc., to obtain the Labeler Code and NDC listing number. Note that fluoride toothpaste, hand sanitizer, disinfectant wipes, sunscreen, wrinkle remover**, anti-acne serum, anti-dandruff shampoo, etc. are all classified by the FDA. The registration cycle of pharmaceutical companies is about 2 months.

FDA registration refers to the process of registration with the U.S. Food and Drug Administration (FDA) to ensure that food, drugs, medical devices, cosmetics and other products sold in the U.S. market meet FDA standards and regulations. Only products that have been registered and approved by the FDA can be sold and used in the U.S. market.

FDA registration involves multiple steps, which include submitting the necessary documents and information to FDA, such as product description, ingredients, manufacturing process, quality control, labeling, and packaging. In addition, other product-related information is required, such as company qualifications, production site information, safety and effectiveness data, etc.

FDA registration applies not only to domestic U.S. businesses and products, but also to overseas businesses and products. Foreign businesses must be registered and approved by the FDA to sell and use their products in the U.S. market. In addition, FDA conducts product audits and inspections to ensure compliance with FDA standards and regulations.

For high-risk products such as medical devices and pharmaceuticals, FDA registration also requires companies to provide additional information and test data to demonstrate the safety and efficacy of the product. This information, including clinical trial data, quality assurance plans, and code-answer risk assessments, is subject to FDA review and approval. After the product is approved by the FDA, the company also needs to comply with FDA regulatory requirements, such as labeling and packaging requirements, regular reporting, production quality control, etc., to ensure the quality and safety of the product.

In general, FDA registration is an important measure to protect the public health of the United States, which ensures that products sold in the American market meet FDA standards and regulations, improves product quality and safety, and protects the rights and interests of consumers. For enterprises, FDA registration and approval can enhance the competitiveness of products in the market and improve the reputation and credibility of the enterprise.

FDA registration, also known as FDA registration. It refers to the action that cosmetics, medical devices, food, lasers, LED lamps and other products exported to the United States must be registered with the Federal Food and Drug Administration, and ensure that the products meet the relevant standards and health and safety requirements of the United States. As drafted:

Clinical Class II and Class III medical products must provide 510K documentation to register with the FDA.

FDA is the abbreviation for the Food and Drug Administration.

FDA certification mainly refers to the following two types:

1. FDA registration: Many products are sold to the United States that need to be registered (such as food, drugs, medical devices, laser products, etc.), and some products must be tested before they can apply for registration.

2. FDA testing: It is to test the product in accordance with FDA regulations.

The FDA is one of the executive agencies established in the U.S. Department of Health and Human Services and the Department of Public Health. It is responsible for ensuring the safety of food, cosmetics, drugs, biologics, medical devices, and radiological products produced or imported by the United States. It was one of the first federal agencies to focus on consumer protection.

Internationally, the FDA is recognized as one of the largest food and drug regulatory agencies in the world. Many other countries seek and receive help from the FDA to promote and monitor the safety of their products.

Low-acid canned food (LACF) refers to any food (except alcoholic beverages) with a finished product equilibrium pH greater than and water activity greater than that, excluding tomatoes and tomato products with a finished product equilibrium pH value less than that. Acidified food (AF) is a low-acid food with added acid or acidic food with a final equilibrium pH of or below and a water activity (AW) greater than. In the early 70s of last century, there were many cases of clostridium botulinum poisoning in the United States due to improper heat treatment of low-acid canned food and acidified food.

The FDA has issued three new regulations, 21 CFR 108 (Emergency Safety Clearance Controls), 21 CFR 113 (Heat-Processed, Low-Acid Foods), and 21 CFR 114 (Acidified Foods), which is the current Good Manufacturing Practice (CCMP) for low-acid canned foods, which came into effect in March 1973. The cGMP for acidified foods (21 CFR 114) came into force in 1979.

The requirements for the registration and process filing of low-acid canned food and acidified food production enterprises are set forth in 21 CFR and 21 CFR respectively. Manufacturers who produce, process, or package acidified low-acid foods must comply with the 21 CFR registration requirements and the 21 CFR process documentation filing requirements. These provisions require the submission of two basic types of electronic **:

FDA Form 2541 for the registration of canned food production; Process documents for filing and registration use the following**:

FDA 2541D (Electronic Process Filing Form for Sterilization of Low-Acid Foods).

FDA 2541E (Electronic Process Filing Form for Sterilization of Acidified Foods).

FDA 2541F (Water Activity Control Food Process Filing Form).

FDA 2541G (Electronic Process Filing Form for Aseptic Sterilization System for Low-Acid Food).

Federal regulations require manufacturers of shelf-stable acidified and low-acid canned foods sold in the U.S. to register with the FDA and submit information on the process, package size, type, and sterilization method for each product, product type, and packaging (21 CFR 108). Enterprises that fail to register and process record in accordance with the requirements of the above laws and regulations will be detained at overseas product ports.

How to register for Anti-Terrorism (FFR), how to apply for Dun & Bradstreet (DUNS), how to register for a Canned Food Factory Number (FCE); How to confirm the registration category of acidified low-acid food and register SID, avoid product detention, and prevent unnecessary economic losses, you can contact the 13683218789 for details, and can provide free consultation and guidance throughout the process.

Different products require different things.

Legal Analysis: Medical Device FDA Recognition Signal Time Period:

Class 1 medical FDA registration cycle: within 1 week.

FDA registration of Class 2 medical devices: about 6 months.

FDA registration for Class 3 medical devices: 10-12 months.

The agency's self-registration FDA approval process can take anywhere from one week to eight months, depending on whether it is self-registering, filing a 510(k) application or submitting a premarket approval (PMA) application, bringing a medical device to market is not a quick process, with studies showing that it takes a total of three to seven years from concept to approval, while drugs take an average of 12 years.

1.Self-enrollment.

Submit. 3.Pre-market approval.

Three-step process:1Pay the registration fee.

2.E-Submit Lists and Registration Information.

3.Receive an acceptance email from the FDA.

Legal basis: "Administrative Measures for the Registration of Medical Devices with Premature Infiltration" Article 32 After receiving the application, the food and drug supervision and administration department shall conduct a formal review of the application materials and deal with them according to the following circumstances: (1) If the application is within the scope of the department's authority, and the application materials are complete and meet the requirements of the formal examination, it shall be accepted;

2) If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to correct them on the spot;

3) If the application materials are incomplete or do not meet the requirements of formal examination, the applicant shall be informed of all the contents that need to be supplemented and corrected within 5 working days, and if the application materials are not notified within the time limit, it shall be accepted from the date of receipt of the application materials;

4) If the application does not fall within the scope of the department's authority, the applicant shall be immediately informed that it will not be accepted.

If the food and drug administration department accepts or refuses to accept the application for registration of medical devices, it shall issue a notice of acceptance or non-acceptance with the special seal of the department and the date.