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Can the sponsor sell the Premarket Approval (PMA) to another company? How does the owner notify FDA of a change in ownership of a medical device?
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 (§814.39) or affect the conditions of approval applicable to the PMA. If changes are made that require a PMA supplement (§814.39) or affect the conditions of approval, the new owner must submit an appropriate PMA supplement and obtain written FDA approval before marketing the device. The above amendment or supplement should also include: the effective date of the ownership transfer; a statement of the new owner’s commitment to comply with all the conditions of approval applicable to the PMA; and either a statement that the new owner has a complete copy of the PMA including all amendments, supplements, and reports or a request for a copy from the FDA files. FDA will provide a copy of the PMA under the Freedom of Information fee schedule. [21 CFR 10.42] A change in manufacturing or product sterilization site and certain changes to the device, labeling, or packaging require prior FDA approval through a PMA supplement. See PMA amendments and supplements for further guidance on when a PMA supplement is required. If the transfer of ownership occurs before the PMA is approved, the PMA must be amended to include the applicable information and ownership transfer letter described above.
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
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