一、What is FDA?

FDA stands for Food and Drug Administration. It is the highest law enforcement agency specializing in food and drug management, authorized by the US Congress and the federal government.

Strictly speaking, there is no such thing as FDA certification, as the FDA itself has stated. Generally, what people refer to as FDA certification mainly includes the following three types: FDA registration, FDA testing, and FDA approval.

① FDA Registration: For companies exporting food, drugs, and medical devices to the United States, they must register with the FDA, including company listing and product listing. Otherwise, customs will not clear the goods. This is a mandatory requirement.

② FDA Testing: FDA testing mainly refers to safety testing of food contact materials, product contact packaging testing, biocompatibility testing of medical products, clinical safety testing, etc.

③ FDA Approval: This generally applies more to drugs, meaning the drug is allowed to be marketed.

二、FDA Responsibilities:

Ensure the safety of food, cosmetics, medical devices, laser radiation products, tobacco, etc., produced in the United States or imported.

三、FDA Scope of Control:

List of product categories regulated by FDA (examples):

Food: Dietary supplements, bottled water, food additives, infant formula, pet food, etc.; Cosmetics: Cosmetic color additives, skin moisturizers and cleansers, nail polish, perfume, etc.;

Medical Devices: Masks, prescription drugs, over-the-counter drugs, human vaccines, dental equipment, surgical implants, prosthetics, etc.; Laser Radiation Products: Microwave ovens, X-ray equipment, sunlamps, etc.;

Veterinary Products: Livestock feed, pet food, veterinary drugs, etc.;

Tobacco Products: Cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, etc.

四、What is FDA Registration:

FDA registration involves registering companies and enterprises to obtain a registration number.

FDA includes several categories such as food, medical products, drugs, cosmetics, food contact materials, etc.

五、Types of FDA Registration:

1. Food FDA Registration

There are some differences from medical device FDA registration.

① Food FDA registration does not require an annual fee in US dollars.

② Renewal is required every even year.

③ After successful food FDA registration, there is no public query method. You need to log in to the background with a username and password to query.

Food FDA Registration Steps:

Step 1: Confirm whether the product falls under FDA food control scope.

Step 2: Select a US Agent.

Step 3: Prepare company and product information in English.

After successful food registration, you will receive the company registration number. The fee includes registration and US agent service. The cycle is 3-5 working days.

2. Medical Device FDA Registration:

Includes two parts: company registration and product listing.

After registration is completed, enter the corresponding registration code, query code, or company name to query relevant information on the FDA website.

The fee includes two aspects: one is the FDA annual fee charged by the United States, which must be paid directly to the FDA Finance in US dollars. The annual fee for the next year must be paid from October 1 to December 31 each year to maintain the validity of the FDA registration, and the annual fee amount varies each year. (The current annual fee for Class I medical devices is $5,546, increasing by hundreds of dollars each year on average.)

The other is the agency fee charged (including company registration, product registration, and US agent).

After successful registration, you will receive three numbers:

① Medical Device Facility Registration Number (Registration or FEI Number)

② Owner/Operator Number

③ Product Listing Number

It is most cost-effective for companies to register with the FDA from October to December each year. After October 1, FDA registration can be used until the end of the next year. Paying one year's annual fee allows the registration number to be used for an additional 3 months.

The FDA registration cycle is 1-2 weeks (after the registrant successfully pays the annual fee to the US FDA). You will first receive the Owner/Operator Number and Product Listing Number, which can be used directly for customs clearance. For devices that have been registered but have not yet obtained the "Medical Device Facility Registration Number", this number can be temporarily used as the "Medical Device Facility Registration Number" for export declaration. The Registration or FEI Number needs to be assigned by the FDA.

3. Cosmetic Registration:

There are two types of FDA cosmetic registration: factory registration and product registration.

Factory Registration: First, apply for an account. After FDA confirmation, submit the registration. Wait for FDA approval. The cycle is 2 weeks.

Product Registration: Product registration requires factory registration first, then submit product ingredients. The cost of ingredient registration increases with the number of ingredients.

After successful cosmetic registration, you will receive the company registration number and CPIS product ingredient filing number (cosmetic registration is similar to food, requiring background login and cannot be directly queried).

4. Food Contact Material FDA Testing Report:

Step 1: Conduct testing according to FDA standards to obtain a test report.

Step 2: After obtaining the test report, we will act as your US agent to check the FDA database to verify whether the corresponding standards meet FDA requirements. Then, issue a certificate of compliance, and finally obtain the FDA certificate of compliance.

六、FDA Certification Process:

1. The applicant signs the "FDA Registration Quotation Contract" and fills out the "FDA Registration Application Form".

2. The applicant returns the stamped application form and contract.

3. Payment notice is sent.

4. The applicant pays the registration fee.

5. Register with the FDA.

6. The applicant receives FDA registration-related information (FDA registration number, password, PIN code, and other relevant information).

7. Technical preliminary review and acceptance.

8. DMF document review.

9. FDA inspection.

10. FDA issues an "approval letter".