eSTAR Submissions, a new method for US FDA Medical Device Submissions – Identifying and Overcoming eSTAR Challenges for a Successful Submission

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As of October 1, 2023, all 510(k) submissions must be submitted as electronic submissions using eSTAR through the CDRH Portal for CDRH or the Electronic Submission Gateway (ESG) for CBER. eSTAR is an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission.

FDA created eSTAR with the following benefits in mind:

  • Guide the submitter to ensure they provide the necessary details for the submission.
  • Complement the reviewers’ internal Submission Memo And Review Template (SMART) used to review the submission, so the reviewer can assess whether they are getting what is expected.
  • Provide a standardized format to make information accessible for both the reviewer and submitter.
  • Automate many aspects of the submission to ensure the content is present, eliminating the need for a Refuse to Accept (RTA) review by the reviewer and RTA holds.
  • Auto fill entered information functionality to avoid entering the same information twice.
  • Include built-in databases to ensure the information relevant for device specific guidances, classification identification, and standards information are auto filled accurately.
  • Include built-in forms (Truth & Accuracy statement, Form 3514, 510(k) Summary, Declaration of Conformity, and the Indications for Use Form 3881).
  • Collect submission data in a structured format to help automate many aspects of FDA processing.
  • Serve as a comprehensive resource to consolidate the necessary information and links needed for submission preparation.

Besides all the benefits that eSTAR provides, the current version of eSTAR comes with several challenges worth understanding in preparation for meeting your submission timelines.  eSTAR challenges include:

  • Performance
  • Single editor capability only
  • Lack of document management and control

Performance:

eSTAR submissions that exceed the 4 GB in size require a different method of submission to the FDA which may create delays to a targeted submission date.   The road to this limitation size, however, is not an easy one in the current version of eSTAR.  As data is entered and documents are attached, the eSTAR submission tool requires more and more time to save and update.   With each addition of attachments  while moving from one data entry to the next, the eSTAR PDF file responds slower delaying significantly the completion of the eSTAR file.   While we anticipate performance improvements in the eSTAR tool with new versions, you will need to plan for the time the eSTAR program needs to incorporate the content you feed into it.   One way to make these performance issues easier to live with is to simulate the creation of an eSTAR submission in advance.  More on this below.

Single Editor Capability:

eSTAR is an offline, stand alone document, designed for a single user.   eSTAR does not allow for collaborators to enter information into eSTAR simultaneously.   Distributing eSTAR information input work using the eSTAR tool alone requires different contributors to use separate eSTAR instances with the further need for consolidation when everyone finishes their assignments.  This kind of segmented consolidation approach can accelerate mistakes.  You may need additional review time on the final submission to avoid unnecessary errors or opt for a different approach.  More on this later.

Lack of document management and control:

eSTAR effectively identifies when a required field is not completed or a require document is not provided.  However, it cannot assess if the information provided is the asked for information.  When eSTAR says all the information has been provided, there is an open question about whether it is the right information.  Submitting via eSTAR with the wrong information is a formula for FDA questions and delays.   One way to prevent this kind of mistake when using eSTAR is to prepare a checklist to facilitate effective review and monitoring of eSTAR submissions.   More about checklists below.

MethodSense’s prescription for eSTAR submission efficiency:

LuminLogic (www.luminlogic.com), developed by MethodSense, is a content and guidance rich software solution specifically designed for Medical Device companies.  LuminLogic is designed to be your eRA/eQA support system.  In addition to the functionality you expect*, MethodSense delivers LuminLogic with ready to use and modifiable SOPs, eTemplates, eProcesses, and Guidance that address a multitude of challenges including eSTAR challenges.   MethodSense has incorporated into LuminLogic eTemplates and checklists that enables collaboration around the pre-defined submission structure and captures all text data ready to be transferred into the eSTAR PDF.  eSTAR Checklist enables proper monitoring and reviewing the work.  LuminLogic manages all files efficiently, enables reviews, revisions and version control throughout the submission process eliminating the need to attach the files to the PDF until it is time to submit.

We welcome the opportunity to demo LuminLogic or talk about how MethodSense consulting services can support you successful eSTAR submission and keep you in compliance.

Click Here to schedule your free LuminLogic demo now!

*LuminLogic functionality:  Document Management, Record Retention, eSignatures, Change Management, Complaint Management, CAPA Management, Training Management, Traceability, Dashboarding, notifications, custom reports and more.

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