Obtain FDA qualifications and methods

It’s a common misconception that FDA is a “certificate.” In reality, FDA operates through mandatory registration + ongoing compliance. Enterprises must complete their corresponding registration process based on product category and continuously meet FDA regulatory requirements. Below is the breakdown by the most common product categories.

Applicable to: Enterprises involved in the production, processing, packaging, or storage of food, beverages, dietary supplements, food contact materials, etc., for export to the U.S.

• Product falls under FDA jurisdiction (except meat/poultry, which is regulated by USDA)
• Must complete Facility Registration with the FDA

• ✅ Registration validity: 2 years (expires at end of even-numbered year)
• ✅ Renewal window: October 1 – December 31 of every even-numbered year
• ⚠️ Missed renewal → FDA removes registration → shipment detention at customs

• FSMA Compliance: Depending on your facility type, may require cGMP compliance, hazard analysis, and preventive controls
• FDA Inspections: Foreign facilities may be subject to on-site FDA inspections
• Food Safety Plan: Must establish written HACCP or food safety plans

Applicable to: Enterprises that manufacture or distribute medical devices (including IVDs).

Step 1: Determine product classification and regulatory pathway
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Step 2: Prepare technical documentation / quality system
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Step 3: Pay establishment registration user fee (DFUF)
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Step 4: Submit registration & listing in FURLS / DRLM
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Step 5: Submit premarket submission (510(k) / PMA / De Novo)

• Search the FDA Product Classification database
• Identify the Regulation Number and Panel
• Determine if a Predicate Device exists for a 510(k) pathway

• Class I/II/III all require compliance with 21 CFR Part 820 (Quality System Regulation)
• Includes: Design controls, production/process controls, CAPA, documentation, etc.

• Pay through the DFUF (Device Facility User Fee) website
• Receive PIN (Payment ID) → after processing, receive PCN (Payment Confirmation Number)
• Small businesses may qualify for fee waivers (requires SBD certification)

• Submit at: FDA FURLS OAA
• Receive an FEI Number (Facility Establishment Identifier) upon completion
• Must also complete Device Listing: declare all devices manufactured and activities performed at the facility

• 510(k) (PMN): Required for most Class II devices. Prove “substantial equivalence” to a predicate device. Review period ≈ 90 days.
• PMA (Premarket Approval): Required for Class III devices. Clinical trials + comprehensive review. ≈ 6–12 months.
• De Novo: For novel devices with no predicate. Request reclassification from III to I/II.
• HDE: Humanitarian Device Exemption (for rare-disease devices).

• ✅ Registration validity: 1 year (calendar year)
• ✅ Renewal window: October 1 – December 31 annually
• ⚠️ Missed renewal → FDA removes registration → shipments detained

Applicable to: Manufacturers of active pharmaceutical ingredients (APIs), finished drug products, and OTC drugs.

• cGMP: 21 CFR Parts 210 & 211
• Drug Establishment Registration: 21 CFR Part 207
• NDC (National Drug Code): Drug listing

• Must submit a Drug Master File (DMF) to FDA for reference by downstream drug manufacturers
• Must comply with ICH Q7 (GMP for Active Pharmaceutical Ingredients)

Note: Cosmetics sold in the U.S. do not require pre-market FDA approval, but there were voluntary programs (VCRP). Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), new requirements have been introduced.

• Cosmetic facilities must register with FDA (mandatory, biennial renewal)
• Must submit Product Listings (CPIS)
• Registration validity: 2 years

Regardless of product type, every enterprise must address these:

All foreign enterprises must designate a U.S. resident or company as their official agent to receive FDA communications and inspection notices.

All registrations must be submitted electronically via the FDA FURLS system. Paper submissions are no longer accepted.

Food: renew every even-numbered year. Devices / Drugs: renew annually. Failure to renew = automatic cancellation = no customs clearance.

Manufacturing processes must comply with FDA’s Good Manufacturing Practices. FDA has the right to conduct on-site inspections at any time (including foreign facilities).

Product labels must meet FDA labeling requirements including ingredient lists, net quantity, manufacturer info, warnings, and allergen statements.

⚠️ The fees are subject to annual adjustment. Please refer to the latest information on the FDA User Fee website for the most accurate details.

Product Classification First: This is the starting point of all work. Incorrect classification will lead to the failure of the entire strategy.
Prepare 6-12 months in advance: The 510(k) review takes 90 days, and the cGMP system construction requires even more time.
Hire Experienced US Agents/Consultants: FDA regulations are complex. Professional US Agents and regulatory consultants can significantly reduce compliance risks.
Establish Quality System Documents: Establish quality manuals, procedure documents, and SOPs in accordance with 21 CFR requirements in advance.
Prepare for FDA Factory Inspection: The FDA factory inspection is a surprise visit. Compliance status should be maintained regularly.

• Applies to: Class III Devices.
• The Mechanism: Pre-Market Approval (PMA).

FDA Approval is the "gold standard" of regulatory review, reserved for high-risk or life-sustaining devices.

To get a device Approved, you must prove—from scratch—that the device is safe and effective. This almost always requires extensive laboratory studies, human clinical trials, and human factors studies. The FDA must give "Approval" before you can market the device.

• If you are making a generic surgical tool: You likely just need to apply general controls, Register and List.
• If you are iterating on existing tech (e.g., a new smart catheter) of a low to moderate risk device: You likely need FDA Clearance (510k).
• If you are inventing a novel low to moderate risk device: You likely need a classification grant (De Novo).
• If you are inventing a life-support system: You likely need FDA Approval (PMA).

Collaborate with professional manufacturers to advance the process

At Haixin Group, we not only produce medical supplies, but also integrate international standards into every detail of the manufacturing process. By resolving all the problems related to the shipping process at the initial stage, we help our customers save time and costs.

Do you have any product requirements and do you need to determine your final generation plan?

Contact Haixin Group immediately for consultation.