USFDA Draft Med.Dev Q&A: Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers

In June 2025, the U.S. Food and Drug Administration (FDA) released a new draft guidance titled “Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers” to address one of the most frequently misunderstood areas in medical device regulation: how to handle the sale or transfer of a 510(k)-cleared medical device. This guidance, aimed at manufacturers, importers, distributors, and regulatory professionals, outlines when a new 510(k) submission is needed, what regulatory steps must be followed after a transfer, and how compliance affects labeling, registration, and Unique Device Identification (UDI) obligations.

This draft document provides clear answers to regulatory questions that often arise during a change in ownership or responsibility for a medical device already cleared under a 510(k).

It focuses on transactions where a company acquires or is assigned the rights to a 510(k)-cleared device without materially changing the device, and therefore does not need to submit a new 510(k).

Who Needs to Submit a 510(k)?

According to the guidance, the following parties typically need to submit a 510(k) if the device is new to commercial distribution:

• Domestic manufacturers

• Specification developers

• Remanufacturers

• Foreign manufacturers

• Reprocessors of single-use devices

If you're simply acquiring a cleared 510(k) without changing the device’s design, indications, or labeling, you generally do not need to file a new 510(k). However, you do become the official 510(k) holder and must meet the associated compliance responsibilities.

What Happens When a 510(k) Is Transferred?

When a 510(k) clearance is sold or transferred, the new holder must update:

1. Device listing in the FDA’s Unified Registration and Listing System (FURLS/DRLM) using the original 510(k) number.

2. Establishment registration, which must occur within 30 days of engaging in manufacturing or distributing activities.

3. Labeling, to reflect the new owner’s company name and location.

4. Unique Device Identification (UDI) data, which must be updated in the Global Unique Device Identification Database (GUDID) if any labeler information changes.

Failure to complete these steps could result in the device being considered misbranded or adulterated, triggering regulatory action.

Do You Need a New 510(k) After a Transfer?

The FDA clarifies that a new 510(k) is not required if the device is unchanged and:

• You are not introducing a new indication for use.

• The design, materials, and performance specifications remain the same.

• The method of manufacture is consistent with the originally cleared device.

However, if you modify the device (even post-transfer), you may need to file a new 510(k). The guidance recommends reviewing the existing FDA documents titled “Deciding When to Submit a 510(k) for a Change to an Existing Device” and “...for a Software Change to an Existing Device.”

Transferring a 510(k) often means the labeling will change to reflect the new entity. The new holder must ensure that:

• All labeling and packaging bear a proper UDI.

• GUDID entries are updated to reflect the new labeler or brand owner.

• Device listing data is complete, accurate, and up to date during the annual October–December FDA registration window.

 Key Resources

• FDA Guidance Document Page

• Download the Draft Guidance (PDF)

• How to Register and List Medical Devices

• Global Unique Device Identification Database (GUDID)

Also, check out this guidance on "Hernia Mesh – Package Labeling Recommendations" to support premarket submissions for hernia mesh devices. This guidance applies to certain surgical mesh devices that are intended for hernia repair.