Transfer of 510(k) Ownership
In today's business climate, a company that sponsors/submits a 510(k) pre-market notification may be acquired or choose to transfer the 510(k) rights to another company for business reasons. When a transfer of 510(k) ownership takes place the Food and Drug Administration (FDA) is not made aware of this change in ownership. FDA only maintains records of the original company that sponsored/submitted the 510(k).
When a transfer of 510(k) ownership occurs, the receiving company should document the transaction and maintain records of the transfer in the same manner as other legal documents. The 510(k) documentation and all subsequent "letters to file" and related 510(k) correspondence with FDA should also be transferred to the acquiring company. These transferred files will be used to understand the baseline of the 510(k) clearance to market and access when/if future changes will require a new 510(k) or a "letter to file" justifying why product changes do not require a new 510(k) submission. FDA may inspect the 510(k) file during a routine or directed inspection.
The previous owner/sponsor/submitter of the 510(k) should send correspondence to FDA:
To make the FDA aware of the new owner of the transferred 510(k), a medical device listing should be made to FDA, using From FDA 2892. After 510(k) transfer of ownership, medical device listing is a method for FDA to identify manufactures by device classification. This identification allows FDA to provide mailings and alerts to manufactures by device classifications.
For support with FDA and International regulations, contact:
Gary Syring, PE, RAC
Quality and Regulatory Associates, LLC
800 Levanger Lane
Madison, WI 53589
Phone: 608 877-2635
Fax: 608 873-7382
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Updated: May 7, 2003