FDA and OMRI Guidance Guide

This guide walks you through FDA and OMRI procedures step by step. Review the registrations and key considerations that are essential when exporting food, drugs, and medical devices to the United States.

Step 1: FDA Facility Registration

• Checklist
• Confirm whether the manufacturing/processing facility is FDA-registered
• Consent to inspections under FSMA
• Description: To export food to the United States, FDA Food Facility Registration is mandatory. Manufacturing and processing facilities must be registered, and you must consent to periodic inspections under FSMA.

Step 2: Submit a Prior Notice

• Checklist
• Submit the Prior Notice within 3-7 days before export
• Submit separately for each shipment
• Description: Before exporting food, a Prior Notice must be submitted for every shipment, and processing takes approximately 3-7 days.

Step 3: OTC Drug Approval Procedure

• Checklist
• Verify the monograph or NDA process
• Review sunscreen and acne-related products
• Description: OTC drugs must be approved through a monograph or a New Drug Application (NDA), and this applies to specific product categories.

Step 4: Medical Device Registration Renewal

• Checklist
• Confirm renewal between October and December each year
• Description: For medical devices, production and distribution facilities must register and renew with the FDA every year.

Key Considerations

• Restrictions on "FDA Approved" claims: Use of the phrase "FDA Approved" is strictly restricted. Supplements may not make disease-related claims.
• About OMRI: OMRI is an organic certification body and may have no direct connection to the FDA.

FAQ

1. Is FDA registration required for all products?
2. Most food, beverages, and drugs require FDA registration, but there are some exceptions.
3. What is a Prior Notice?
4. A Prior Notice is a procedure for notifying the FDA in advance when exporting food, and it must be submitted for each shipment.
5. Is OMRI certification related to the FDA?
6. OMRI is an organic certification body with no direct connection to the FDA, but it can serve as a reference for organic products.

Tags

• FDA Guide
• OMRI Guidance
• Exporting to the US
• Food Safety
• Medical Device Registration