Can the sponsor sell the PMA to another company? How does the owner notify FDA of a change in ownership?
Yes, a PMA may be sold to another company. The sponsor must submit a PMA amendment to notify FDA of the new owner. The new sponsor is responsible for complying with the PMA regulatory requirements as well as all other applicable regulations such as registration, listing, quality system, and medical device reporting. The PMA reference number will remain the same. Ownership of a PMA may be transferred at any time, i.e., before or after FDA approval. At the time of the transfer, the former owner should provide an original and a copy of a letter (preferably on the letterhead of the former owner and signed by an appropriate company official) to be used to notify FDA that all rights of the PMA have been transferred to the new owner. If the PMA has been approved, the new owner need only report that the transfer of PMA ownership will not result in a change or modification that would require a submission of a PMA supplement (ยง814.39) or affect the conditions of approval applicable to the PMA. I
