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Can the Premarket Approval (PMA) holder enter into a licensing agreement with another medical device 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 holder has furnished the licensee with a complete copy of all manufacturing information in the approved PMA applicable to the licensee’s manufacture of the device; a complete description of a licensee’s manufacturing facilities and a listing and explanation of all differences between the original PMA holder’s and the licensee’s methods and controls used in the manufacture, processing, packing, storage, and, when appropriate, installation of the device; process validation and expiration dating information, where appropriate; copies of all required labeling (draft or final) and a description of all differences between the PMA holder’s and the licensee’s labeling (e.g., a markup of the PMA holder’s approved labeling identifying the revisions incorporated in the licensee’s labeling; a description and the results of all tests and evaluations which demonstrate that the licensee’s device is identical or sufficiently similar to the PMA holder’s device to the extent that there is reasonable assurance that the licensee’s device is safe and effective for the intended use; and the licensee’s FDA establishment registration number and, if applicable, the dates of the most recent FDA inspection of the licensee’s manufacturing facility.
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
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