Registering and Listing Your Medical Devices for 2024
Every October, the FDA’s registration and listing window opens, and medical devices of all shapes, sizes, colors, and claims manage to list themselves, effortlessly finding their special place in the agency’s registration and listing database for the next twelve months.
If only it were that easy.
Over the next three months, medical device manufacturers must update or complete the registration and listing of their devices and facilities using the FDA Unified Registration and Listing Systems.
If you’re producing or distributing products intended for the U.S. market, compliance with FDA regulations is essential. In this quick update, we’ll walk through the latest updates, essential preparations, the role of U.S. Agents, potential challenges, and how we can assist you.
Who, When, and How Much?
Who
The annual establishment registration process applies to owners or operators of establishments that are involved in the production and distribution of medical devices intended for use in the United States. Does your company fall into this category? Get specifics directly from the FDA here.
When
FDA Registration opens every year from October 1 to December 31. While you can register outside this window, it’s best practice to do so within these dates. Remember, registration is required every year! If you have a new product that receives clearance outside of this window, you will need to register and list your facility and device within 30 days of clearance.
How Much
Stay updated on the latest user fees, typically released in August. The current year’s fee is $7,653, regardless of having a small business designation.
At a glance —
Establishment registration (Title 21 CFR Part 807) requires owners or operators of establishments that are involved in the production and distribution of medical devices intended for use in the U.S. to register annually with the FDA.
All device establishments required to register must complete their annual registration for each Fiscal Year between October 1 and December 31.
What’s New This Year?
Registration is fully electronic, and FDA frequently updates the system to streamline the process further. This year, among other updates, the FDA has introduced Multi-Factor Authentication (MFA) to enhance security.
The Status of FDA Industry Systems page indicates the MFA process will go live for all FIS user accounts on October 13, 2023. Make sure you review and update your account information before October 12.
Key Info You’ll Need to Begin.
An Individual Account
Before you start, you’ll need access to an individual account. FDA discourages sharing accounts, so begin by creating one for yourself.
Device or Product Labeling
It will help streamline the process if you have device or product labeling in front of you.
Facility Information
Even if you are simply repackaging or importing products, you’ll still need to submit information regarding your facility. Don’t forget to agree on the primary contact at the facility. You’ll need to provide this to complete the process.
FDA Point of Contact
If someone other than yourself will be the primary contact regarding the registered device, you’ll also need their information ahead of time. Contact information for a U.S. Agent is required for entities outside the United States.
U.S. Agents – Who Are They? Do I need One?
U.S. Agents play a vital role in FDA communications. They assist with inquiries, help schedule inspections, and act as intermediaries when contacting foreign establishments.
If you need a U.S. Agent or aren’t sure, contact us. We represent many clients as their U.S. Agent and can step in to help you as well.
Published Instructions, Potential Challenges.
While the FDA provides instructions for registration and listing, nuances can be tricky, and sometimes, the instructions may not match updated screens or steps in the process. For instance, registering certain products such as EUAs or Convenience kits can require additional detail not stipulated in the provided instructions. If you get stuck, don’t worry. Help is available.
Some browsers and equipment may not operate correctly with the FURLS and DLRM systems. These include MAC personal computers, Internet Explorer 8.0, wide screen monitors, and browsers such as Firefox or Google browser (CHROME).
Getting Help With Your Device Registration and Listing.
In addition to the numerous resources and instructions, you can get answers about your specific situation directly from the FDA. Just know that the turnaround isn’t instant.
If you need help now or an answer sooner than later, contact us. At MDC, we offer a range of services to ensure your Registration and Listing journey is smooth.
Navigating FDA Registration and Listing may seem daunting, but it becomes a manageable process with the right guidance and support. Remember, assistance is always available, and we’re here to help you every step of the way.
From initial setup to serving as your U.S. Agent to yearly product registration and listing renewal, we’ve got you covered.
Contact us today to simplify your compliance journey and ensure your medical devices meet the highest safety and quality standards.
