US FDA regulatory scoping and documentation support for eligible food, cosmetic and medical-device businesses entering the United States.
Who this service is for
Suitable for manufacturers, exporters and importers of FDA-regulated product categories. The exact scope is agreed after reviewing the product, location, applicable standard or buyer requirement.
How Fusion Certification supports you
- Identify product classification and the relevant FDA legal route.
- Assess registration, listing, controls, labelling and foreign supplier obligations.
- Help prepare documentation and specialist regulatory coordination.
Scoping and certification considerations
FDA does not issue generic “FDA certification” for food facilities, and requirements differ substantially by product type.
Independent consultancy: Fusion Certification provides guidance, implementation, documentation and audit-readiness support. Certification, registration, testing and formal approvals are issued only by the authorised independent body or scheme authority.