This article highlights the procedure, key points and Benefits of the USFDA eSTAR Submission Programme.
Table of Contents
eSTAR Submission
According to the FDA announcement in September, businesses can now submit premarket applications electronically via the CDRH Customer Collaboration Portal (eCopy or eSTAR) (“CDRH Portal”).
Every medical device applicant seeking to submit 510(k)s and De Novo requests to the Center for Devices and Radiological Health (CDRH) or the Center for Biologics Evaluation and Research may voluntarily use the eSTAR for free.
Currently, the eSTAR cannot be used with combination products.
1.In Vitro Diagnostics eSTAR Version 1
2. Non-In Vitro Diagnostic eSTAR Version 2
This program enhances quality submissions with appropriate supporting data in a respected format with a complete application that helps medical device commercialization.
This eSTAR is an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission.
Contents of the Template:-
- Automation (for example, form construction and autofill)
- Content and structure that is complementary to CDRH internal review templates
- Integration of multiple resources (for example, guidance and databases)
- Guided construction for each submission section
- Automatic verification
How do I prepare for eSTAR submission?
Online preparation:
The FDA published two versions of eSTAR. For IVDR and Non-IVDR on the FDA portal. Companies can submit eSTAR via the CDRH portal.
All 510(k) submissions, save those exempted by Section VI, include initial submissions for Traditional, Special, and Abbreviated 510(k)s, as well as any supplements, amendments, or other subsequent submissions to an original submission.
The guidance’s Waivers and Exemptions From Electronic Submission Requirements must be submitted electronically.
The application sub-eSTAR type is a response to a request for more details.
The eSTAR will include an additional area where you can respond to FDA requests for further information when you declare your intention to do so.
This section will be located close to the end of the document.
By Mail
Submit eSTAR by mail to CDRH’s Document Control Center (DCC)
U.S. Food and Drug AdministrationCenter for Devices and Radiological Health
Document Control Center (DCC): WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Important Notes
The eSTAR is exempt from following the eCopy Guidance document’s requirements and is not required to be compressed and stored in a MISC FILES folder. Although the FDA highly advises against it, any additional files delivered in addition to the eSTAR PDF must adhere to the eCopy Guidance document.
Applicants for CBER premarket notification (510(k)) submissions who wish to use the voluntary eSTAR Program are free to use the Center for Biologics Evaluation and Research (CBER) pilot program.
The goal of CBER’s voluntary eSTAR Pilot Program is to give applicants experience with the internal procedures for 510(k) submissions utilizing the eSTAR template as well as the review of those submissions.
What is the Review Timeline for eSTAR?
RTA (Refuse to accept) Review: within 15 Days
Substantive Review: Within 60 Days
Decision Letter: Within 90 Days
For Additional Information (AI) Requests: within 180 days to submit additional requested documents or information.
If the eSTAR submission is incomplete when it is filed, the FDA will email the submitter to let them know what information is missing and put the submission on hold for 180 days or until a replacement eSTAR with all the missing information is submitted to the FDA.
The remainder of a 510(k) review will be conducted according to the FDA guidance, while A De Novo classification request will be reviewed according to 21 CFR p860, Subpart D, and as described in the FDA guidance.
Benefits of eSTAR submissions
The main benefit of eSTAR is being able to immediately confirm that your submission is finished.
The status statement “eSTAR Complete” will appear at the top of the PDF if you correctly completed your eSTAR submission.
The eSTAR PDF will show when each part is finished during the submission process.
Additionally, the form is automated, adding or removing elements in accordance with the specifications for your submission.
The documentation that should be included in the submission is reduced when filing using eSTAR.
The Medical Device User Fee Cover Sheet and other FDA-provided paperwork are already included in the interactive PDF, so they don’t need to be completed separately and attached.
With eSTAR, submission packages are more efficiently organized.,the eCOPY Program must be used when uploading documents to a flash drive, CD, or DVD for traditional filing methods.
Each file in the submission can have a maximum file size of 50MB, and if the filenames are named incorrectly, the FDA may decline to accept the submission during the RTA review.
With eSTAR, all that is required in the submission package to be delivered to the FDA is the printed cover letter and the eSTAR PDF stored onto a flash drive, CD, or DVD. As there is only one file (with embedded attachments), there is no need to adhere to the eCOPY Program rules.
Guidance of eSTAR submission
“Electronic Submission Template for Medical Device 510(k) Submissions.
What next?
As per FDA guidance, this program is voluntary. However, All 510(k) filings must be made electronically using eSTAR as of October 1, 2023, unless exempted.
How Can RegDesk Help?
RegDesk is a holistic Regulatory Information Management System that provides medical device and pharma companies with regulatory intelligence for over 120 markets worldwide. It can help you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Global expansion has never been this simple.
