The U.S. Food and Drug Administration (FDA) has released a new draft guidance providing guidance on frequently asked questions regarding the transfer of a premarket notification (510(k)) clearance from one 510(k) holder to another.
When a 510(k) clearance is transferred, the new holder must list the device in the FDA Unified Registration and Listing System (FURLS) via the Device Registration and Listing Module (DRLM) if listing is required.
If the device has not been significantly modified, the new holder must provide the original FDA-assigned premarket submission number. If a new 510(k) is submitted due to changes, the new submission number must be used.
For manufacturers contemplating or executing mergers and acquisitions activities, this guidance describes how previously cleared devices are handled during company sales or transfers. This includes any person introducing a device into commercial distribution for the first time, or significantly changing an already distributed device.
The FDA has opened a public comment period, allowing stakeholders to submit their feedback online or via mail by August 4, 2025. NSF PROSYSTEM advises manufacturers, particularly those with active M&A projects, to review this draft guidance thoroughly and consider submitting comments to the FDA.
