The regulator plans changes to both IDE and Emergency Use Authorization (EUA) in order to bring them more in line with Premarket Approval (PMA) and Humanitarian Device Exemption (HDE) submissions. Although PMA and IDE submissions and reviews will no doubt remain the most complex and time-consuming processes in the FDA’s arsenal, the technological adjustments underway should at least remove some of the more unnecessary challenges to bringing high-risk and novel devices to market in the US. Among the improvements planned: Requests for new clinical protocols, changes to protocols or device changes will be tracked as supplements. IDE reports will now be tracked as reports rather than as supplements. IDE submissions sent as responses to deficiencies in previous applications will be tracked as amendments rather than as supplements.
Under the current system, all materials submitted to the FDA related to existing IDE submissions were considered supplements only. For IDEs involving multiple studies, FDA reviewers will also track all studies using a single IDE submission number. According to the regulator, such steps will allow the Center for Devices and Radiological Health to more effectively track clinical trials, IDE approvals and study completions. To further improve the IDE submission process, the FDA advises that applicants address only one issue per IDE submission—protocol modification, deficiency letter response and adverse event reporting are three different issues, for example, and should be submitted separately to FDA reviewers. Will these improvements result in less confusion and more streamlined timeframes for manufacturers undergoing FDA PMA review for their medical devices? Clinical investigation requirements make up a significant and expensive component of PMA reviews; if nothing else, providing more information to applicants on how to effectively submit IDE-related materials and improving underlying processes should lead to fewer surprises for manufacturers. These process updates will apply to IDE submissions received on or after August 18, 2013.
REFERENCE: Emergo Group; Stewart Eisenhart; July 30, 2013