A Premarket Approval (PMA) is an application made to FDA to obtain
marketing clearance. It is the FDA process of scientific and regulatory
review to evaluate the safety and effectiveness of Class III medical
devices.
Service
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Organizing and reviewing the original materials and product information
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Organizing and reviewing manufacturing process and control materials
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Preparing PMA package
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Submitting PMA materials to FDA
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Correspondence with FDA
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Routine maintenance of approved PMA (Annual report, change report, and notification…)
Link to "Services" for more information.