For Class III medical devices and devices that employ novel methods of treatment and are not substantially equivalent to currently marketed medical devices, manufacturers must submit a Premarket Approval Application to the FDA. A PMA is much more complex and time-consuming to prepare than a 510(k). A PMA submission typically contains a significant quantity of clinical, animal testing, manufacturing, and other data, all of which the FDA carefully scrutinizes.After a PMA is submitted, the FDA usually assembles a scientific advisory panel to study the PMA . The panel, comprising physicians and other experts in fields relevant to the submission, may hold a public meeting during which the PMA is reviewed and discussed. After evaluating the data in the PMA, the panel will recommend to FDA that it be approved, approved with conditions, or not approved.
510(k) Premarket Notification. Medical devices that are substantially similar to products already on the market can usually obtain FDA clearance via the agency's premarket notification process, known as a 510(k).. This review process is required for a few class I devices, most Class II devices and some Class III devices. In a 510(k) filing, the FDA requires that medical device manufacturers provide information and data (which may include clinical data) demonstrating that the new device is substantially equivalent to previously marketed devices and does not raise any new questions with respect to safety or efficacy.