About US FDA Registration
US FDA (Food and Drug Administration) registration and compliance is required for organisations exporting food, beverages, dietary supplements, medical devices, cosmetics, and pharmaceutical products to the United States โ one of the world's largest and most lucrative markets. FDA requirements vary significantly by product type, and non-compliance can result in import alerts, detention of shipments, and legal liability.
Our US FDA Registration Services
- Food facility registration (required every 2 years under FSMA)
- Medical device establishment registration and device listing
- Cosmetics facility registration (now required under MoCRA)
- Dietary supplement facility registration and product labelling compliance
- Prior Notice for food imports
- 510(k) premarket notification for medical devices
- Pharmaceutical Current Good Manufacturing Practice (cGMP) compliance
- FDA inspectability preparation for overseas facilities
Why Work With ISOAsia?
ISOAsia has guided hundreds of Asian businesses through US FDA Registration and related compliance programmes. Our consultants combine deep regulatory knowledge with practical implementation experience โ ensuring your certification project is completed efficiently, correctly, and to the highest standard.
Free Initial Consultation: Not sure if US FDA Registration is right for your product or business? WhatsApp our specialists for a free, no-obligation assessment of your requirements.
Frequently Asked Questions
Any facility that manufactures, processes, packs or holds food, beverages, dietary supplements, medical devices, cosmetics, or pharmaceuticals for US import/sale requires FDA registration or notification.
Food facility registration must be renewed every two years (in even-numbered years). Medical device establishment registration must be renewed annually.
A 510(k) is a premarket submission proving that a medical device is substantially equivalent to a legally marketed predicate device. Most Class II medical devices require 510(k) clearance before US market entry.