Published by: E&E Medicals and Consulting | Website: https://eemedicals.com/ | Category: FDA Registration
Introduction
Before a medical device can be legally marketed in the United States, the manufacturer must register their establishment and list their devices with the FDA. This process, known as FDA establishment registration and device listing, is a fundamental regulatory requirement. E&E Medicals and Consulting provides expert FDA registration consulting services to ensure your registration is completed accurately and on time FDA registration consultant.
What is FDA Establishment Registration?
FDA establishment registration is the process by which medical device manufacturers, contract manufacturers, and other facilities involved in the production of medical devices register their facilities with the FDA. Registration must be completed annually between October 1 and December 31 each year.
Device listing is a separate but related requirement in which manufacturers provide the FDA with information about the devices they manufacture or distribute. Device listing must be updated whenever a new device is introduced or an existing device is significantly changed.
Step-by-Step FDA Registration Process
- Step 1 — Determine if Registration is Required: Not all establishments are required to register with the FDA. E&E Medicals helps you determine whether your facility and device require registration.
- Step 2 — Obtain a DUNS Number: A Data Universal Numbering System (DUNS) number is required for FDA registration. E&E Medicals guides you through this process.
- Step 3 — Create an FDA Account: You will need to create an account in the FDA’s registration and listing system (FURLS). E&E Medicals assists with account setup and navigation.
- Step 4 — Complete Establishment Registration: E&E Medicals prepares and submits your establishment registration, ensuring all required information is accurate and complete.
- Step 5 — Complete Device Listing: E&E Medicals prepares your device listing, including product codes, regulation numbers, and device descriptions.
- Step 6 — Pay Registration Fees: FDA charges annual registration fees. E&E Medicals ensures you understand and comply with all fee requirements.
- Step 7 — Annual Renewal: E&E Medicals provides ongoing support to ensure your registration is renewed annually and your device listing is kept current.
Common Registration Mistakes to Avoid
Many companies make avoidable mistakes during the FDA registration process, including registering under the wrong establishment type, incorrect product code selection, outdated device listing information, and missed renewal deadlines. E&E Medicals and Consulting ensures none of these mistakes happen with your registration.
Frequently Asked Questions
Q: Is FDA registration the same as FDA approval?
No. FDA registration is an administrative requirement for all medical device establishments. FDA approval or clearance (through 510(k), PMA, etc.) is a separate process that authorizes the marketing of specific devices. E&E Medicals assists with both processes.
Q: What happens if I miss the FDA registration deadline?
Failing to register or renew your FDA registration can result in enforcement action, including import alerts and seizure of products. E&E Medicals helps ensure you never miss a registration deadline.
Q: Can foreign manufacturers register with the FDA?
Yes. Foreign manufacturers whose devices are exported to the U.S. must register with the FDA. E&E Medicals and Consulting has extensive experience assisting international clients with FDA registration requirements.
Conclusion
FDA establishment registration is a critical first step for any medical device company entering the U.S. market. With E&E Medicals and Consulting managing your registration, you can be confident that it is completed correctly, on time, and in full compliance with FDA requirements. Contact them at https://eemedicals.com/.
For more information, visit https://eemedicals.com/ or contact E&E Medicals and Consulting at info@eemedicals.com | Phone: +1-678-385-6106 | Address: 400 Galleria Parkway, Suite 1500, Atlanta, GA 30339
────────────────────────────────────────────────────────────
E&E Medicals and Consulting | 400 Galleria Parkway, Suite 1500, Atlanta, GA 30339
Email: info@eemedicals.com | Phone: +1-678-385-6106
Website: https://eemedicals.com/