New guidances outline eSTAR submission requirements for de novo and 510(k) device applications
The US Food and Drug Administration is one step closer to requiring electronic submission of all premarket applications for both 510(k) and de novo medical devices, according to two newly released draft guidances on the matter.As of 1 October 2023, all 510(k) applications must be submitted through the electronic Submission Template And Resource (eSTAR) program portal, according to the draft guidance on 510(k) applications.
“This date includes a transition period of a minimum of one year prior to the requirement that all 510(k) submissions be provided as electronic submissions,” the guidance notes. “During the transition period, eSTARs may be used voluntarily for 510(k) submissions …FDA only intends to accept 510(k) submissions saved to a form of electronic storage media and mailed to FDA if they are received by FDA before October 1, 2023.”
For de novo applications, however, the eSTAR-only shift is still in process.
“By September 30, 2025, FDA intends to identify a specific date on which we will require that De Novo requests be provided as electronic submissions. We anticipate that from the time we announce a date, there will be a transition period prior to requiring that all De Novo requests be provided as electronic submissions,” FDA wrote.
Until that time, eSTAR de novo submissions are voluntary.
“When a date is identified, this draft guidance will be updated and finalized to provide that specific date and set forth the electronic format(s) specified in this guidance that must be used for submission of De Novo requests,” according to the guidance.
Only fully paid applications will be accepted and put through the automatic screening process, which will ensure that all questions have been answered and all necessary documents attached.
“The technical screening process is anticipated to occur within 15 days of FDA receiving the … eSTAR,” both drafts note. “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would then have 180 days to file a replacement eSTAR; if that doesn’t happen, the application will be considered withdrawn.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.
The draft guidances for both de novo and 510(k) eSTAR submissions include some exemptions from the process. Sponsors will not be required to use the eSTAR program for interactive review responses and amendments (appeals or requests for supervisory review, substantive summary requests, changes in correspondent amendments, and amendments after final decision). Exemptions for 510(k) submissions also included withdrawal requests.
The agency noted that it does not intend to grant requests for waivers for de novo or 510(k) submissions, saying “FDA has not identified any particular circumstances appropriate for a waiver of the [510(k) and De Novo] electronic submission requirements and does not intend to grant requests for waiver.”
Both guidances are part of a federally required process to develop a secure, automated electronic submission process for industry. The requirement originated in the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter. The goal was to completely shift to electronic submissions for these premarket applications through the eSTAR program, which launched in June 2022.
eSTAR is the only electronic submission template now available that facilitates the preparation and submission of de novo and 510(k) applications. It consists of a collection of questions, text, logic, and prompts within a template that guides a user through construction of a complete application. It is also linked to FDA’s integrated databases, with the goal of making it easier to find and add additional information like product codes, consensus standards, and regulations.
De novo guidance
510(k) guidance
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