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Can I obtain a copy of a Premarket Approval (PMA) submission for a medical device?
Upon approval (or denial of approval) of any PMA, FDA will publicly reveal the existence of the PMA and provide a detailed summary of the information submitted to FDA about the safety and effectiveness of the device. The approval order, summary of safety and effectiveness, and product labeling are available on the Internet and are linked from the searchable PMA database. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm In addition, the following types of information in the PMA file are available for public disclosure after deletion of any trade secret, confidential commercial or financial information, or any other information that if disclosed would constitute a clearly unwarranted invasion of personal privacy, e.g., personnel, medical, and similar information. The releasable information includes: all safety and effectiveness data and information previously disclosed to the public; any protocol for a test or study; any adverse reaction report, product experience report, consumer complaint, and other similar data and information; a list of components previously disclosed to the public; an assay method or other analytical method; and all correspondence and written summaries of oral discussion relating to the PMA file. The following types of information are not available for public disclosure unless they have been previously disclosed to the public, relate to a device for which a PMA has been abandoned, or no longer represent a trade secret or confidential commercial or financial information: manufacturing methods or processes including quality control procedures; production, sales, distribution, and similar data and information; and quantitative or semiquantitative formulas. [21 CFR 814 and 21 CFR 20]
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
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