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FDA Issues Guidance for Transfer of 510(k) Clearance

On December 22, 2014, the U.S. Food and Drug Administration (FDA) issued a draft guidance regarding the transfer of a premarket notification (510(k)) clearance.  If a medical device establishment sells a device that is not 510(k)-exempt to another company, it can include the 510(k) clearance for the device along with  the sale.  As long as the new owner of the device does not significantly change or modify the device, FDA does not require a new 510(k) submission.

In the past, FDA has had trouble tracking the history of 510(k) holders.  So, in 2012, FDA modified its regulations to require device establishments to include their FDA-assigned 510(k) number in their device listing information.  This way, when device establishments complete their required annual listing updates, FDA is presented with updated information about the 510(k) holder for a specific device.  Aside from updating their listing information, device establishments are not required to give FDA additional notification of the transfer of ownership of a 510(k).  FDA does, however, recommend that the current 510(k) holder maintain documentation of the transfer of a 510(k) clearance.

Since there may be only one 510(k) holder for a specific device,  if two entities list the same 510(k) number in the same annual listing period, FDA’s 510(k) database will show the person who listed their device most recently as the 510(k) holder.  FDA will contact both companies that listed the number and attempt to determine a single 510(k) holder.  If the situation cannot be resolved by FDA, the company may submit evidence, such as a court order or verification from the previous holder, to be established as the rightful 510(k) holder.  If a 510(k) holder is determined, and the other company is found to have been marketing a device without the required 510(k) clearance, that company would be in violation of the Food, Drug, and Cosmetic Act.

Any device that is not listed with FDA is considered misbranded.  For assistance with listing a medical device or for help reviewing a 510(k), contact Registrar Corp.