On August 18th, 2013, medical device manufacturers filing Investigational Device Exemption (IDE) will encounter a more streamlined and updated application process, according to the US Food and Drug Administration. Changes to both IDE and Emergency Use Authorization (EUA) will converge with Premarket Approval (PMA) and Humanitarian Device Exemption (HDE) submissions. Although PMA and IDE submissions and reviews are multifaceted and particularly time-consuming, the approaching technological modifications will decrease several of the challenges to introducing high-risk and innovative devices to market in the US.
Several improvements include:
- 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.
- FDA reviewers will also track all studies using a single IDE submission number 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.
Will these advancements result in less confusion and more streamlined timeframes for manufacturers undergoing FDA PMA review for their medical devices? These improvements will provide more information to applicants on how to effectively submit IDE-related materials and enhance underlying processes, resulting in fewer surprises for manufactures.
Read more: FDA Guidance on IDE Application Approvals