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.
FDA’s primary consideration in determining when a new IVD requires a PMA is the level of risk to patient health that information obtained from use of the IVD may have in the event of an erroneous test result. In this context, FDA seeks to understand whether the proposed new IVD will be used in a manner that will uniquely and substantively affect diagnostic or therapeutic interventions for a particular disease or condition
FDA may grant marketing approval for a biological product on the basis of adequate and well-controlled clinical trials establishing that the biological product has an effect on a surrogate endpoint that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to predict clinical benefits or on the basis of an effect on a clinical endpoint other than survival or irreversible morbidity.