As of October 1, 2023, all U.S. FDA 510(k) submissions, unless exempted, must be submitted as electronic submissions using the eSTAR platform. In this column, Dr. Dhriti Roy, vice president of Regulatory Affairs Transformation at Essenvia and faculty at Oxford University’s MedTech innovation platform, discusses the benefits and challenges companies can expect as they transition to this new submission process.
Dr. Roy has more than 20 years of experience in MedTech, leading quality, regulatory and clinical strategies for large and early-stage organizations. She specializes in 510(k)s, IDEs, PMAs, MDRs, IVDRs, FDA QSR, compliance with SIMDs and SAMDs, and is involved in global regulatory efforts for M&A deals.
What is the new FDA eSTAR submission process, and what can we expect next?
Dr. Roy: eSTAR is an interactive PDF that helps applicants submit a complete medical device application.
All medical device 510(k) submissions to the Center for Devices and Radiological Health (CDRH) or Center for Biologics Evaluation and Research (CBER) must use eSTAR, which is free. eSTAR is voluntary for CDRH/CBER medical device De Novo submissions and CDRH medical device pre-submissions. eSTAR also accepts combination products and Dual 510(k)/CLIA Waiver IVDs.
eSTAR allows submitters to provide comprehensive data for premarket review for various medical devices. Its standardized format helps submitters complete their submissions, and allows the FDA to conduct premarket reviews more efficiently to promote timely access to safe, effective and high-quality medical devices.
Electronic submissions created with this template are called eSTARs for simplicity, and eSTAR updates are almost entirely timed by policy updates. The CDRH is asking for quarterly policy updates with an implementation date for the start of the next quarter.
What are the main benefits of eSTAR?
Dr. Roy: The eSTAR program improves transparency and consistency in the submission process by providing a standardized format, a guided procedure and comprehensive collection of data and materials.
Key benefits include:
- Assists submitters in providing required information.
- Ensures the reviewer gets what they expect, and that the questions match the internal Submission Memo And Review Template (SMART) used to review the submission.
- According to the FDA, a standard format through eSTAR makes information accessible to reviewers and submitters.
- Automates many submission steps to ensure content is complete, eliminating Refuse to Accept (RTA) reviews and holds. FDA does not plan an RTA review for eSTAR.
- Auto-fills information to avoid duplication.
- Has built-in databases to auto-fill device-specific guidance, classification and standards information.
- Truth & Accuracy statement, Form 3514, 510(k) Summary, Declaration of Conformity, and Indications for Use Form 3881 are built in.
- Structured submission data helps automate FDA processing.
- Offers a complete source of submission preparation information and links.
- Transparency and consistency are enhanced by eSTAR’s standardized format, guided procedure and increased thoroughness.
- Allows users to quickly and easily view the status of the submission
- Decreases records of documentation
- Saves time and resources
- Obviates the need for numerous lesser PDF files.
- Assists the submitter in guaranteeing the inclusion of essential information.
What are the main eSTAR challenges?
Dr. Roy: There are many challenges users can experience. These include:
- Online eSTAR viewing is not possible on browser from a cloud storage platform.
- eSTAR makes team collaboration almost impossible.
- Multiple users cannot work simultaneously. This increases the time to get ready for submissions.
- Manufacturers need to purchase full licenses for PDF viewing tools to use eSTAR.
- For many regulatory professionals, eSTAR creates more confusion, rather than simplifying the submission process.
- There is a steep learning curve for the regulatory professionals.
- This is not an enterprise-grade solution. It creates siloed operations within regulatory departments.
- Though the FDA says the standard format through eSTAR makes information accessible to reviewers and submitters, in reality, it creates more issues in accessing data for submission teams.
- There is no online form or interface where multiple users can work simultaneously with the support of workflows.
- The Truth & Accuracy statement, Form 3514, 510(k) Summary, Declaration of Conformity, and Indications for Use Form 3881 do not add any value.
- Though it was built to assist submitters in providing the required information, its rule-based conditional events make the form difficult to use, and it is challenging to estimate the level of effort required to complete one submission.
- There is no use of modern path-breaking technologies such as cloud or AI.
What actions should regulatory professionals take to overcome the main challenges posed by eSTAR?
Dr. Roy: The regulatory teams need to build an eSTAR process, which may include the following steps:
- In a shared network drive or on any cloud platform, create a root-level folder for each submission.
- Inside that root-level folder, create one folder for each section of the eSTAR file.
- Download and save the eSTAR file in the root folder.
- In each section folder, teams can store the Word files that will eventually be attached to the eSTAR file.
- Use a separate project management tool to allocate tasks among team members for each submission.
- Create separate processes and workflows to track the authoring and reviewing process for each attachment.
- One individual should fill out the eSTAR form.
- Another individual or more than one can review the eSTAR file.
- Before attaching the file to the eSTAR file, the content of the attachments must be reviewed and approved.
- Finally, when the eSTAR file is ready for submission, a submitter should log into the Customer Success Portal to submit the file.
The eSTAR process is time-consuming, and there are many points where collaboration is difficult to achieve. Hence, we always recommend that companies use a collaborative platform for submission preparation not only to speed up the submission process but also to increase the rate of acceptance of their submissions by the FDA.