FDA Medical Device Registration and Listing: A Practical Guide for Manufacturers
If you’re a manufacturer hoping to sell medical devices in the United States, FDA registration and listing is one of the first things you’ll need to deal with. The FDA wants to know who is making devices, where they’re made, and what those devices are. Once you understand how the process works, it’s far less intimidating than it looks.
What Registration and Listing Actually Mean
These are two separate pieces that work together:
- Establishment registration tells the FDA about your facility and what it does, whether that’s manufacturing, repackaging, distributing, or something else.
- Device listing tells the FDA which specific products those facilities make or handle.
Both requirements fall under 21 CFR Part 807.
How the Process Works
Here’s the typical path from start to finish:
- Check whether you need to register. Your obligations depend on what your establishment does, so start by confirming where you fall.
- Set up a FURLS account. This is the FDA’s online system for registration and listing.
- Pay the annual user fee. The establishment registration fee is due each year.
- Enter your establishment details. You’ll provide facility information, ownership details, and the business activities carried out on site.
- List your devices. Include device names, classification, and any premarket submission numbers that apply.
- Review and renew. Registration isn’t one-and-done. You’ll need to confirm your information every year.
Compliance Points to Keep in Mind
Most establishments must renew between October 1 and December 31 each year, so it’s worth putting that window on your calendar early. Foreign manufacturers also need to name a US Agent, who acts as the point of contact for FDA communications.
One misunderstanding comes up constantly: registering with the FDA is not the same as FDA approval or clearance. Registration simply puts your establishment and devices on record. If your device needs 510(k) clearance or Premarket Approval (PMA), you must get that authorization before you can legally market it.
Where MASUU Global Fits In
Paperwork and regulatory details can eat up a lot of time, especially if you’re new to the US market. MASUU Global helps manufacturers with FDA medical device registration, regulatory documentation, and compliance guidance, so your team can stay focused on building great products.