How to Complete FDA Annual Facility Registration: A Step-by-Step Overview
This video highlights the step-by-step process for completing the FDA annual facility registration, a mandatory requirement for medical device businesses operating under FDA jurisdiction. The registration period runs from October 1 to December 31, and it’s recommended to allow extra time—up to two weeks—to address any potential issues.
Key points covered include:
- Verifying the FY 2025 registration fee ($9,280).
- Accessing and navigating the FDA Unified Registration and Listing System (FURLS) to pay the user fee.
- Understanding the importance of the Payment Identification Number (PIN) and Payment Confirmation Number (PCN) for successful registration.
- Logging into the Online Account Administration (OAA) system to finalize the process.
The video emphasizes the importance of referring to FDA-provided instructions, which clearly outline each step. Links to these resources and additional guidance are included here for ease of access.
Completing the registration is straightforward with proper preparation—watch the video for a clear and concise guide.