Starting October 1, 2023, all 510(k) submissions must be submitted using the FDA’s new eSTAR interactive PDF. Whether you’re submitting a traditional or special 510(k), or submitting a medical device or in vitro diagnostic 510(k), the eSTAR will become the only way to submit premarket notification submissions.
The FDA’s new eSTAR brings numerous advantages over typical eCopy submissions. First, the interactive eSTAR template makes the refuse-to-accept (RTA) review obsolete; the RTA review is replaced by a technical screening and virus scanning that occurs. In addition, before you can submit an eSTAR, the pdf acts as a smart template by tracking and listing any sections that require attachments or more details to complete, which will help clear that first review hurdle. And should your submission require additional information during substantive review, the eSTAR pdf will have saved all attached documentation that was originally submitted, so responding to additional information requests from the FDA is as simple as adding a new document to the eSTAR and resubmitting.
Full implementation of eSTAR means changing the way you approach and configure regulatory submissions. The most important difference is that the eSTAR template is a complex interactive PDF that will react to your entries in its input fields. Your initial inputs lead to automated sections that become active or inactive based on your responses. And the whole document automatically keeps track of the information you provide, making the submission writing process that much easier. But the submission process can still pose complicated challenges. To help make the submission process smoother, the FDA is constantly revising the eSTAR template and releasing new versions for both IVD and non-IVD device submissions. With every new version comes a new set of automated elements, verification processes, and bookmarked document sections that will have to be completely satisfied before submission is possible. If an eSTAR is marked incomplete, it will not be submissible.
Time is running out! Contact RQMIS today for all your regulatory needs. RQMIS has a team of experienced regulatory and technical writers who have submitted eSTARs since FDA’s Pilot Program period, so we’re prepared to help with your questions about the new format and craft the best submission possible. We can organize your bench testing, biocompatibility, and cleaning verification results to ensure that when it gets in front of a reviewer, your data is exactly where it needs to be to make a compelling argument for substantial equivalence. Our team can help guide you through the automated elements and sections of eSTAR preparation, so you’re not left guessing when new fields pop up based on your initial inputs.