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US FDA registration support
Registration support for exporting to the United States. Typically about 7 working days after complete documents, payment and review.
The FDA does not issue registration certificates, and registration is not FDA approval. Do not describe your facility or products as FDA approved or use the FDA logo.
What is US FDA registration?
Businesses that make or handle food, drugs, medical devices or cosmetics for the United States market must meet US FDA requirements. For food facilities this means registering with the FDA and naming a US agent. We guide you through registration and issue a certificate confirming the registration details.
Who needs it?
- Food and beverage exporters to the US
- Supplement and herbal product exporters
- Cosmetic manufacturers
- Medical device makers and their exporters
Review the US FDA registration preparation checklist
What it can do for your business
- Clear list of what the FDA requires for your product
- Registration details in one document for buyers
- Fewer shipment holds at US ports
- Reminders before renewal is due
FROM ENQUIRY TO REVIEW
How it works
01
Define the support needed
Describe your activities, the relevant product or service and the question the review should address.
02
Confirm scope and fees
Agree the service deliverable and its limitations, buyer requirements and any additional costs before payment.
03
Gather current records
Prepare your initial business documents and evidence for the service-specific checklist below.
04
Complete the review
Respond to requests for missing information and review any identified gaps or next steps.
05
Check the deliverable
Confirm what the resulting record demonstrates. Refer to the service disclosure above for limits on certification, registration or approval claims.
STARTING YOUR APPLICATION
Initial business documents
These establish who is applying and the proposed business scope. They are the starting point; the service-specific review or assessment can require additional operational evidence.
Business registration
Udyam, incorporation certificate or shop licence.
Letterhead or visiting card
Your business name and contact details.
One business invoice
A recent sales or purchase invoice.
Your business scope
What you do, in one or two clear lines.
Prepare for US FDA registration
Use these registration support for exporting to the united states checks to organise your preparation. For each item, identify the responsible person, the procedure used and a recent record showing what happens in practice.
- Identify the FDA product category and the rules that apply
- Register the facility with the FDA
- Appoint a US agent
- List products where listing is required
- Renew registration within the FDA renewal period
Make your evidence match your scope
- Describe the actual activities and locations to be reviewed, including outsourced work and responsibilities retained by your business.
- Choose current examples from your own operation. Record the date, responsible person and outcome so the reviewer can connect the evidence to your stated scope.
- Identify missing records or unfinished actions before assessment. A policy or blank template alone does not show how a process operates.
- Ask which records apply to your selected service and scope. This preparation checklist is not an exhaustive assessment or a promise of certification.
The FDA does not issue registration certificates, and registration is not FDA approval. Do not describe your facility or products as FDA approved or use the FDA logo.
BEFORE YOU COMMIT
Confirm these details in writing before payment
Use the published price alongside the agreed scope and service terms when deciding whether the offering meets your requirement.
- Scope and deliverable: the applicable standard or scheme, edition, activities, sites and exclusions, and exactly what document or support the service provides.
- Issuing or assessment body: its name and role. If accredited certification is required, confirm the accreditation body and that the relevant standard and scope are covered.
- Buyer acceptance: share the actual tender or customer clause and confirm that the proposed route meets it. A certificate title alone does not establish acceptance.
- Assessment arrangements: required documents, audit or review stages, remote or on-site work, travel, readiness requirements and expected timing.
- Fees and exclusions: the selected service price, what is included, and any separate implementation, testing, site visit, travel or statutory registration costs.
- Ongoing obligations: applicable surveillance, renewal or reassessment, their fees, and how changes to your activities or locations should be reported.
Certification and accreditation have different roles. See ISO's guidance on choosing a certification body.
Questions about US FDA registration
01Does the FDA issue a registration certificate?+
No. The FDA assigns a registration number but does not issue certificates. Certificates of registration are issued by third parties.
02Does registration mean FDA approval?+
No. Registration is not approval of the facility or its products, and the product must not be advertised as FDA approved.
03How often is food facility registration renewed?+
Every two years, in the renewal period set by the FDA in even-numbered years.
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