U.S. FDA certification

I. Core Concepts and Classification of FDA Registration

1. Responsibilities and Regulatory Scope of the FDA

The FDA is responsible for overseeing the safety and effectiveness of the following products:

Food: including processed foods, additives, dietary supplements, etc.

Drugs: prescription drugs, over-the-counter (OTC) drugs, biologics, etc.

Medical Devices: from low-risk (Class I) to high-risk (Class III) equipment.

Cosmetics: skin care products, hair dyes, perfumes, etc.

Laser Radiation Products: such as laser marking machines, projectors, etc.

2. Distinction of Registration Types

FDA Testing: Targeted at material safety (e.g., food contact materials) and biocompatibility testing.

FDA Approval: Applicable only to drugs, requiring clinical trials to verify safety and efficacy.

FDA Registration: A mandatory requirement covering facility registration and product listing, serving as a prerequisite for customs clearance and sales.

II. Detailed Explanation of the FDA Registration Process

1. Preliminary Preparation

Product Classification: Determine the specific category of the product (e.g., medical devices are classified into Class I, II, and III).

Document Preparation:

Company information (name, address, U.S. agent, etc.).

Product technical documents (design drawings, ingredient lists, label descriptions).

Safety assessment (e.g., food testing reports, clinical trial data for medical devices).

2. Application Submission

Online system: Submit through the FDA Unified Registration and Listing System (FURLS) or dedicated platforms (e.g., laser products must be submitted via email).

Fee payment: Certain categories require annual fees (e.g., the annual fee for medical devices is $11,423, based on the 2026 standard).

3. Review and Approval

Technical Review: The FDA evaluates the completeness and compliance of the documentation and may request additional materials or conduct an on-site inspection.

Approval Milestone: Once a registration number is obtained (e.g., 510(k) or PMA approval for medical devices), the product can be legally marketed.

4. Ongoing Compliance

Renewal Requirements:

Food facilities must renew every two years (October–December of even-numbered years).

Medical device establishments need to renew annually and pay the annual fee.

Post-market Surveillance: The FDA will conduct random product inspections and review adverse event reports; companies must maintain their quality management systems.

III. Key Points for Major Product Registration

1. Food Category

Applicable Entities: Both manufacturers and exporters are required to register and must designate a U.S. agent.

Key Documents: D-U-N-S number, ingredient testing reports, production process flow chart.

2. Medical Device Category

Classification and Pathway:

Class I: Low risk, direct registration (e.g., surgical gloves).

Class II: Moderate risk, requires submission of a 510(k) premarket notification (e.g., blood glucose meters).

Class III: High risk, requires PMA application and clinical trials (e.g., cardiac stents).

3. Cosmetics Category

Voluntary Registration: Companies may apply for an FEI number and register product ingredients, which remain valid indefinitely.

Labeling Compliance: Must clearly list ingredients, warning statements, and manufacturing information.

4. Pharmaceutical Category

Strict Approval Process: New drugs must go through stages such as IND (Investigational New Drug application) and NDA (New Drug Application), which can take several years.

IV. Registration Timeline

Differences in Timelines:

Food registration: 3–5 business days (excluding D-U-N-S application).

Medical device 510(k): Varies by classification (e.g., Class I: 1–2 weeks; 510(k) requires 4–8 months or more).

Cosmetics: 1–2 weeks.