Pre-market Approval PMA

The pre-market approval process is a considerably more complex procedure, as the FDA can only grant marketing approval on the basis of an assessment of the actual safety and effectiveness of the device in question. Thus, it is similar to a drug 

A 4-page form that collects basic information on the notification Covering Letter 

Identifies the device and gives a brief outiine of the device Table of Contents User Fee Information 

A copy of a completed Medical Device User Fee Coversheet, which permits checking that the review fees have been paid 

Identifies reference device or standard and rationaie for claiming equivalence / conformity. Labelling 

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PMA Pre-Market Approval Application (FDA) Pharmaceutical Manufacturers Association (now PhRMA) (equivalent to NDA for Class III Devices)... 

OTA staff developed the survey instrument with the assistance of OTA project advisory panel members and Pharmaceutical Manufacturers Association (PMA) senior management. It contained seven questions pertaining to total clinical trial enrollment, total number of therapeutic indications for which the company sought FDA approval, the total number of clinical studies completed (both pre-and post-NDA), and the total number of trial sites. OTA asked companies to provide these numbers broken down by foreign and domestic research and by whether or not the clinical studies were completed before or after first FDA (NDA) marketing approval. 

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