Can the PMA holder enter into a licensing agreement with another manufacturer?
When the holder of an approved PMA enters into an agreement to permit another firm (hereafter referred to as the licensee) to manufacture and distribute a device under the licensee’s private label, FDA approval may be obtained by the following procedure: The licensee may submit an original PMA that includes, or includes by authorized reference to the holder’s approved PMA, all appropriate information required by 21 CFR 814.20. After the licensee’s PMA is approved, the original PMA holder may not rescind any authorization permitting the licensee’s use of information in the original approved PMA. The licensee may also use that same information in support of changes or modifications later proposed by the licensee. The licensee becomes independent of the original PMA holder and should submit all required PMA supplements and periodic postapproval reports directly to FDA. The PMA submission must include the following: • a statement signed by both parties confirming that the original PMA hold
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