FDA Registration
US FDA facility registration and Prior Notice for food, cosmetics, and medical device exporters to the United States. Expert guidance through FDA registration requirements.
Standard
US FDA 21 CFR
Service type
Outsourcing service
Issued under
Accredited partner CB
What it is
The US FDA (Food and Drug Administration) requires food facilities, cosmetic manufacturers, and medical device companies exporting to the USA to register their facilities and comply with relevant 21 CFR regulations. CAS supports Egyptian and regional manufacturers through the FDA registration process via established US regulatory affairs partners.
Who needs it
Food manufacturers, cosmetics producers, pharmaceutical companies, dietary supplement manufacturers, and medical device producers wishing to export products to the United States market.
Benefits of certification
- Required for all food and medical device exports to the USA
- Guidance from experienced US regulatory affairs specialists
- Covers FSVP (Foreign Supplier Verification Program) requirements
- Prior Notice filing support for food shipments
- Ongoing compliance monitoring and renewal support
- Combined with ISO 22000 / FSSC 22000 for full food safety compliance
Frequently asked questions
Common questions
Is FDA registration mandatory for all food exporters to the USA?
Yes. Under the FDA Food Safety Modernization Act (FSMA), all food facilities that manufacture, process, pack, or hold food for human or animal consumption in the US must register with the FDA.
What is Prior Notice?
Prior Notice is the FDA requirement to notify them before food shipments arrive in the US. CAS can assist with Prior Notice filing through our regulatory affairs partners.
Ready to certify against US FDA 21 CFR?
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