What is FDA Certification & What is FDA Registration?

 What is FDA Certification & What is FDA Registration?

I. What is the FDA? The FDA, authorized by the U.S. Congress (the federal government), is the highest law enforcement agency specializing in food and drug regulation. Its full name is the Food and Drug Administration.

Strictly speaking, there is no such thing as FDA certification; the FDA itself has stated this. Generally, when people talk about FDA certification, they are referring to the following three types: FDA registration, FDA testing, and FDA approval.

① FDA Registration: Companies exporting food, drugs, and medical devices to the United States must register with the FDA, listing their company and products. Otherwise, customs clearance will be denied; this is a mandatory requirement.

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

③ FDA Approval: This usually applies to pharmaceuticals, meaning the drug is allowed to be marketed.

II. FDA Responsibilities: Ensuring the safety of food, cosmetics, medical devices, laser radiation products, tobacco, etc., produced or imported into the United States.

III. FDA Scope of Regulation: List of product categories regulated by the FDA (enumerated):

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

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

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

Tobacco Products: Cigarettes, rolled tobacco, self-rolled cigarettes, smokeless tobacco, etc.

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IV. What is FDA Registration?

FDA registration is the process of registering a company or business and obtaining a registration number.

The FDA has several categories, including food, medical products, drugs, cosmetics, and food contact materials.

V. Types of FDA Registration

1. Food FDA Registration

This differs from medical device FDA registration in several ways.

① No annual fee in US dollars is required for food FDA registration.

② Renewal is required every even-numbered year.

③ There is no publicly available way to check the status of a successful food FDA registration; you need to log in with your username and password to view the information.

Food FDA Registration Steps:

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

Step 2: Choose a US agent.

Step 3: Prepare company and product information in English.

After successful food registration, you will receive a registration number. The fee includes registration and US agent services, and the processing time is 3-5 business days.

2. Medical Device FDA Registration

This includes company registration and product listing.

After registration, you can find relevant information on the FDA website by entering the corresponding registration code, query code, or company name.

The fees include two aspects: one is the annual FDA fee charged by the US government, which must be paid directly to the FDA in US dollars. The annual fee is due from October 1st to December 31st each year to maintain the validity of the FDA registration. The annual fee amount varies each year. (The current annual fee for Class I medical devices is $5546, increasing by several hundred dollars annually on average.)

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

After successful registration, you will receive three numbers:

① Medical Device Facility Registry Number (FEI Number)

② Owner/Operator Number

③ Listing Number

It is most cost-effective for companies to register with the FDA between October and December each year. Registering after October 1st allows the registration number to be used until the end of the following year, extending the validity of the registration number by three months by paying the annual fee.

FDA registration takes 1-2 weeks (after the company successfully pays the annual fee to the FDA). Upon successful registration, an Owner/Operator Number and a Product Registration Number (FEI Number) will be issued, allowing for direct customs clearance. Equipment that has been registered but has not yet obtained a Medical Device Facility Registry Number (FEI Number) can temporarily use this number for export customs declaration. The FEI Number, however, needs to be assigned by the FDA.

3. Cosmetic Registration

FDA cosmetic registration has two types: factory registration and product registration.

Factory Registration: First, an account is applied for. After FDA confirmation, the registration is submitted. FDA approval takes about 2 weeks.

Product Registration: Product registration requires factory registration first, followed by submission of product ingredients. The cost of ingredient registration increases exponentially with the ingredients.

After successful cosmetic registration, you will receive a company registration number and a CPIS product ingredient filing number (similar to food registration, this needs to be viewed in the backend and cannot be directly queried).

4. FDA Test Report for Food Contact Materials

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

Step 2: After obtaining the test report, we, as your US agent, will check with the FDA database to verify whether the corresponding standards meet the relevant FDA requirements. A certificate of conformity will then be issued, and you will ultimately obtain an FDA certificate of conformity.

VI. Validity Period of FDA Certification/Registration

Cosmetics FDA

Valid indefinitely after successful certification.

All cosmetics sold in the United States, whether locally manufactured or imported, must comply with the regulations issued by the Regulatory Commission and require the establishment of a voluntary cosmetic registration program.

Medical Devices FDA

Valid for one year, renewed annually in October.

The FDA Modernization Act requires all companies engaged in the production, formulation, distribution, synthesis, assembly, processing, or import/export of medical devices to register with the FDA.

Laser Radiation (FDA)

Valid for one year, renewed annually in July

Laser-related products include: laser pointers, laser demonstrators, laser displays, products containing laser units (DVDs, CD-ROMs, CD players, laser printers, etc.), safety protection, and emergency medical products.

Pharmaceuticals (FDA)

Valid for one year, renewed annually in October

All manufacturers of pharmaceuticals intended for the diagnosis, treatment, symptom relief, management, or treatment of diseases must register with the FDA and declare all their ingredients.

Food (FDA)

Renewed every even-numbered year

All U.S. and non-U.S. companies that manufacture, process, package, or store food or pharmaceuticals intended for consumption in the United States must register with the U.S. Food and Drug Administration (FDA).

VI. FDA Certification Process:

1. The applicant signs the FDA Registration Quotation Contract and completes the FDA Registration Application Form;

2. The applicant returns the application form and contract after stamping them;

3. Payment notice is sent;

4. The applicant pays the registration fee;

5. Registration is processed with the FDA;

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

7. Initial technical review and acceptance of the application;

8. Review of DMF documents;

9. FDA inspection;

10. FDA issues an "Approval Letter"

Frequently Asked Questions about the FDA:

Q: Which agency issues FDA certificates?

A: FDA registration does not issue certificates. Once a product is registered with the FDA, it will obtain a registration number. The FDA will send the applicant a reply letter (signed by the FDA Commissioner), but there is no such thing as an FDA certificate.

Q: Does the FDA require testing by designated certification laboratories?

A: The FDA is an enforcement agency, not a service agency. If someone claims to be an FDA-approved laboratory, they are at least misleading consumers. The FDA does not have public-service certification agencies or laboratories, nor does it have any so-called "designated laboratories." As a federal law enforcement agency, the FDA cannot act as both judge and player. The FDA only conducts GMP quality accreditation for service-oriented testing laboratories and determines whether to issue a certificate of conformity based on the circumstances, but it does not designate or recommend any specific laboratories to the public.

Q: Is a U.S. agent always required for FDA registration?

A: Yes, companies must appoint a U.S. citizen (company/organization) as their agent when registering with the FDA. This agent is responsible for providing process services in the U.S. and acts as the intermediary between the FDA and the applicant.

Q: Do I need to send samples for FDA registration?

1. FDA registration differs from CE certification. Its certification model differs from the product testing + report certificate model of CE certification. FDA registration actually adopts a declaration of good faith model, meaning you are responsible for your product's compliance with relevant standards and safety requirements and register it on the U.S. federal website. If a product issue arises, you will bear the corresponding responsibility. Therefore, for most products, FDA registration does not involve sending samples for testing or issuing certificates. Q: Does the FDA registration have an expiration date?

2. FDA Registration Validity: The validity period of FDA registration for most products is one year. After one year, re-registration is required, and the annual fee will need to be paid again.

Q: Is there a certificate for FDA registration?

Actually, there is no certificate for FDA registration. After a product is registered with the FDA, it will obtain a registration number, and the FDA will send the applicant a reply letter (signed by the FDA Commissioner). However, there is no such thing as an FDA certificate. The certificate we usually see is issued to the manufacturer by an intermediary agency (registration agent) to prove that they have helped the manufacturer complete the "manufacturing facility registration and product type registration" required by the US FDA. The sign of completion is that they have helped the manufacturer obtain an FDA registration number.

Q: What is 510k certification?

A: Based on different risk levels, the FDA classifies medical devices into three classes (I, II, III), with Class III having the highest risk level.

The FDA clearly defines the product classification and management requirements for each medical device. Currently, there are more than 1,700 medical device product catalogs in the FDA, containing nearly 6,000 product codes. Any medical device seeking market access in the United States must first understand the product classification and regulatory requirements.

Once this information is clear, companies can begin preparing the necessary application materials and submit them to the FDA according to established procedures to obtain approval. For any product, company registration and product listing are also required.

FDA Classification of Medical Devices:

Class I products (approximately 47%) are subject to general control. The vast majority of these products only require registration, listing, and compliance with GMP (Good Manufacturing Practice) regulations to enter the US market (a very small number of products are exempt from GMP, and a very small number of reserved products require a 510(k) application, or PMN (Premarket Notification), to the FDA).

Class II products (approximately 46%) are subject to special control. After registration and listing, companies must implement GMP and submit a 510(k) application (a very small number of products are exempt from 510(k)).

Class III products (approximately 7%) are subject to premarket approval. After registration and listing, companies must implement GMP and submit a PMA (Premarket Application) to the FDA (some Class III products also require a PMN).

For Class I products, after submitting relevant documents to the FDA, the FDA only issues a public notice and does not issue any certificates. For Class II and III devices, companies must submit a Product Name (PMN) or Product Approval Document (PMA). The FDA, along with the public notice, will issue a formal market access approval letter, allowing the company to directly sell its products in the US medical device market under its own name.

Whether an on-site GMP assessment is conducted at the company during the application process is determined by the FDA based on a comprehensive evaluation of factors such as product risk level, regulatory requirements, and market feedback.

In summary, most products can obtain FDA certification after company registration, product listing, implementation of medical device GMP, or submission of a 510(k) application