The tutorial from FDA provides a comprehensive guide for registering a cosmetic product facility using the FDA’s Cosmetics Direct portal. Here is a step-by-step summary:

1. Home Page Access:
   • After creating an account and logging into the FDA Direct, navigate to the “Registration of Cosmetic Product Facility” under the Cosmetic Registration and Listing section.
2. Creating a New Registration or Uploading an Existing File:
   • Users can create an initial Cosmetic Product Facility Registration using a blank form or import an FDA-accepted SPL (Structured Product Labeling) file in a valid XML zip format.
3. Document Type Details:
   • There are five document type options: Initial Registration, Abbreviated Renewal, Amendment, Biennial Renewal, and Cancellation. Each type has specific requirements and alert messages.
4. Registration Details:
   • Users must fill in mandatory fields (indicated by a red asterisk) and provide information such as the US Agent Contact Information if the facility is outside the US.
5. Brand Names:
   • Users can add multiple brand names of the cosmetic products manufactured or processed at the facility. Each brand name should be saved and categorized appropriately.
6. Confirmation and Additional Contact Information:
   • Users must agree to a confirmation statement and provide additional contact information for the authorized agent.
7. Upload a SPL File:
   • Users can upload a pre-existing SPL file (in XML zip format). The system will auto-fill the form fields based on the uploaded file.
8. Registration Status:
   • The system provides various status updates such as “Validation in Progress,” “Ready for Submission,” “Submission Accepted,” and “Validation Failure.” Users must address any validation errors before final submission.
9. Save and Validate:
   • Users can save their progress as a draft at any stage. The system allows for an initial validation check before the actual submission to the FDA.
10. Submission:
    • After completing the form and addressing any errors, users can submit the SPL to the FDA. Successful submissions will receive a submission ID and the option to view and download the SPL.

Application Flowchart

Here is the flowchart for the application process based on the tutorial:

1. Login to FDA Direct
   • Access the “Registration of Cosmetic Product Facility” section.
2. Select Registration Option
   • Create New Registration
   • Upload Existing SPL File
3. Document Type Selection
   • Choose from:
     • Initial Registration
     • Abbreviated Renewal
     • Amendment
     • Biennial Renewal
     • Cancellation
4. Fill Registration Details
   • Complete mandatory fields.
   • Provide US Agent Contact Information (if applicable).
5. Add Brand Names
   • Add and save brand names and categories.
6. Agree to Confirmation Statement
   • Provide additional contact information.
7. Upload SPL File (if applicable)
   • System auto-fills fields based on uploaded file.
8. Save and Validate
   • Save progress as draft.
   • Validate for errors.
9. Address Validation Errors (if any)
   • Fix errors and re-validate.
10. Submit SPL to FDA
    • Receive submission ID.
    • Option to view and download SPL.

This flowchart highlights process for registration and compliance with FDA requirements for cosmetic product facilities.

REFERENCE

CosmeticsDirect. (2024). CosmeticsDirect facility registration tutorial. U.S. Food and Drug Administration. Retrieved from https://www.fda.gov/cosmetics/cosmetics-news-events/deadline-registration-and-listing-cosmetic-product-facilities-and-products-what-does-deadline-mean