In June 2025, the U.S. Food and Drug Administration (FDA) issued a long-anticipated draft guidance that clarifies the process for transferring ownership of 510(k) clearances. The document: “Transfer of a Premarket Notification (510(k)) Clearance” addresses long-standing ambiguity around when and how a 510(k) can be transferred between organizations, particularly during mergers, acquisitions, and spinouts.

At Quality Solutions Now (QSN), we see this as a significant development with direct implications for companies navigating ownership changes, joint ventures, or portfolio divestitures. The new draft guidance is a welcome effort to create consistency, but it also raises new compliance considerations for regulatory, quality, and legal teams.

Why This Matters

The 510(k) program is one of the most commonly used regulatory pathways for bringing low- to moderate-risk devices to market in the U.S. Yet, until now, there was no formal process for transferring a 510(k) clearance from one company to another.

Historically, companies handled transfers informally by updating device labeling, contacting the FDA reviewer, or submitting a new Device Listing with a different manufacturer name. The lack of a defined process has led to confusion, especially when modifications are made post-transfer or when multiple entities claim ownership.

The new guidance aims to establish a consistent, traceable, and transparent framework for these ownership changes.

Key Takeaways from the Draft Guidance

Here are the most important highlights from the FDA’s proposal:

1. Ownership Transfer Must Be Documented in Writing
FDA expects a written agreement between the current 510(k) holder and the receiving party, clearly outlining the terms of the transfer.

2. Notification to FDA Is Strongly Recommended
While not mandatory, FDA encourages the new owner to submit a letter to the 510(k) database team confirming the transfer and requesting an update to the FDA’s public 510(k) database.

3. Device Modifications Require Careful Review
If the new owner intends to modify the device, they must evaluate whether those changes require a new 510(k), per FDA’s 2017 guidance on “Deciding When to Submit a 510(k) for a Change.”

4. Only One Entity May Hold the Clearance at a Time
To avoid regulatory ambiguity, FDA affirms that only one company can hold a given 510(k) clearance at any point in time. Co-ownership is not recognized.

5. Importantly: Transfer Does Not Automatically Cover Related Files
The 510(k) clearance does not include rights to associated Master Files, Design History Files (DHF), or Manufacturing Process Documentation unless those are explicitly included in the business transaction.

Implications for MedTech & Biotech Companies

The draft guidance is especially relevant for:

• Private equity-backed rollups acquiring multiple device assets

• Startups divesting non-core products or selling business units

• Large strategics acquiring smaller 510(k)-cleared platforms

• Contract manufacturers taking on additional regulatory responsibilities

Ownership of a 510(k) clearance brings not only market access. It brings liability, post-market surveillance obligations, and QMS alignment requirements. With clearer FDA expectations, companies will now need to align their regulatory filings and internal records to match the public 510(k) database.

How to Prepare

If your organization is planning or has recently completed a device acquisition, licensing agreement, or carve-out, here’s what we recommend:

• Conduct a 510(k) Ownership Audit
  Ensure the publicly listed holder of record matches internal documentation and labeling. If not, take steps to submit a transfer notification to FDA.
• Review All Change History and DHF Files
  If you’re inheriting a 510(k), confirm that you also have access to the full design history, test data, and quality system documentation. If you don’t, you may need to resubmit.
• Update Quality & Regulatory SOPs
  Integrate FDA’s transfer expectations into your change control, regulatory strategy, and quality management procedures. This will help avoid gaps during audits or future submissions.
• Evaluate Need for New 510(k)
  If you’re planning to update labeling, indications, or the manufacturing process after a transfer, perform a thorough regulatory impact assessment.

QSN Perspective

This draft guidance helps close a long-standing regulatory grey area, but it also raises the bar for diligence and documentation. Companies that fail to formally recognize and manage 510(k) transfers could face misaligned device listings, labeling issues, and even enforcement action if post-market surveillance obligations are not clearly assigned.

At QSN, we’ve supported clients through regulatory due diligence, post-acquisition compliance integration, and FDA communications related to 510(k) ownership. We can help ensure your documentation, labeling, and systems reflect current expectations, so your product stays compliant and market-ready. Contact us to see how we can help.