The US Food and Drug Administration (FDA) has issued two guidance documents relating to the use of the eSTAR (electronic Submission Template And Resource) submission process, which became the mandatory route for 510(k) submissions on 1 October 2023.
The two guidances are:
Both documents were issued on 2 October 2023.
While 510(k)s must now be submitted through eSTAR, de novo applications will still be able to be submitted as eCopies via the Customer Collaboration Portal for a few more years yet, as the date for publication of the end of any de novo transition period may not be published until September 2025.
The guidances confirm that only fully paid applications will be accepted and put through an automatic screening process, which will ensure that all questions have been answered and all necessary documents have been attached.
“The technical screening process is anticipated to occur within 15 days of FDA receiving the … eSTAR,” but “If the eSTAR does not pass technical screening, FDA will notify the submitter via email and identify the incomplete information, and the [submission] will be placed and remain on hold until a complete replacement eSTAR is submitted to FDA.”
The sponsor would then have 180 days to file a replacement eSTAR; if that doesn’t happen, the application will be considered withdrawn. For applications that do pass the technical screening, however, the review time clock starts on the day the submission was received.