TL;DR: FDA (Food and Drug Administration) oversees food contact materials, medical devices, cosmetics, dietary supplements, and drugs sold in the US. FDA registration is mandatory for the manufacturing facility (not just the product). The process and cost vary widely by product category.
FDA Product Categories
| Category | Requirements | Cost | Timeline |
|---|---|---|---|
| Food contact materials | Facility registration + FDA compliance testing | $2,000 – $5,000 | 4–8 weeks |
| Medical devices (Class I) | Facility registration + 510(k) exempt listing | $5,000 – $10,000 | 1–3 months |
| Medical devices (Class II) | 510(k) premarket notification + QMS | $10,000 – $50,000+ | 3–12 months |
| Cosmetics | Facility registration + product listing (MoCRA) | $2,000 – $8,000 | 2–6 weeks |
| Dietary supplements | Facility registration + GMP + labeling | $5,000 – $15,000 | 2–4 months |
Food Contact Materials (Most Common)
If your product touches food (kitchen utensils, food storage containers, cookware, food processing equipment), it must comply with FDA food contact regulations:
- Register the Chinese factory: The manufacturing facility must register with FDA (renewed annually in October–December).
- US Agent: Chinese factories must designate a US-based agent who can be contacted by FDA.
- FDA compliance testing: Materials must be tested per FDA 21 CFR (e.g., migration testing for plastics, heavy metals for ceramics).
- Prior Notice: FDA must be notified before food/food-contact shipments arrive in the US.
Medical Devices from China
China is a growing source of medical devices (Class I and II). Key requirements:
- Establishment registration: Both the Chinese manufacturer and US importer must register with FDA.
- Quality Management System: Factory must operate under QMS (typically ISO 13485).
- 510(k) clearance: Most Class II devices need 510(k) premarket notification showing substantial equivalence to a legally marketed device.
- MDR (Medical Device Reporting): Ongoing obligation to report adverse events.
MoCRA: New Cosmetics Regulation
The Modernization of Cosmetics Regulation Act (MoCRA), effective since 2023, requires:
- Facility registration for all cosmetic manufacturing and processing sites.
- Product listing with ingredients for each marketed cosmetic.
- Adverse event reporting within 15 business days.
- Good Manufacturing Practice (GMP) compliance.
- Proper labeling including allergen declarations.