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# Guide on 510(k) Transfers/Sales
- URL: https://www.fdaweb.com/guide-on-510-k-transfers-sales/
- Published: 2025-06-04T12:00:00.000Z
- Updated: 2026-09-14T15:13:25.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159302

FDA has released a [draft guidance ](https://www.fda.gov/media/186765/download?ref=fdaweb.com)entitled “Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers.” The document provides information on the most frequently asked questions regarding the transfer or sale of a 510(k) clearance from one application holder to another. It discusses topics related to a transfer or sale of a 510(k) clearance in which the submission of a new 510(k) would not be required, and instances in which entities must use the existing 510(k) number to list a device.