The United States Food and Drug Administration (USFDA) introduced the electronic Submission Template and Resource (eSTAR) program as part of its efforts to modernize and streamline medical device submission. This initiative aims to streamline the 510(k)-submission pathway, which is essential for manufacturers seeking to bring new medical devices. As of Oct 1, 2023, the use of eSTAR has become mandatory for all 510(k) submissions, making a pivotal shift towards digital advancement in the regulatory process. The adoption of FDA eSTAR is expected to enhance the efficiency and clarity of submissions, ultimately benefitting both manufacturers and regulatory reviewers.
Understanding FDAs eSTAR
The eSTAR is designed as an interactive PDF form that guides users through the submission process. It includes a series of questions and prompts tailored to specific device types, ensuring that all necessary information is collected systematically. The template’s key features include:
Guided prompts and questions: Each section of the eSTAR template is accompanied by detailed instructions and questions that help manufacturers provide relevant information.
Standardized format: By utilizing a standardized format, eSTAR facilitates consistency across submissions, making it easier for FDA reviewers to assess and compare different applications.
Integration with FDA review processes: The eSTAR template is integrated with the FDA review process through the Submission Memo and Review Template (SMART) system.
Procedure for Preparing eSTAR Submission
Advantages of eSTAR submission
The FDA’s eSTAR program offers several advantages that contribute to a more efficient submission and approval cycle for medical devices.
Elimination of Refuse to Accept (RTA) review: The eSTAR eliminates the need for Refuse to Accept (RTA) review by ensuring submissions are complete and correctly formatted. The eSTAR portal will automatically scan whether the submission is complete or not. The RTA removal allows submissions to move directly into the substantive review, thereby accelerating the overall review timeline.
Streamlined regulatory submissions: The eSTAR is a standardized electronic template that streamlines regulatory submissions by consistently organizing them, reducing time spent on understanding different formats and layouts.
Reduction of regulatory burdens: The eSTAR reduces regulatory burdens by simplifying documentation requirements and reducing paperwork, saving time and costs associated with preparing submissions. It also enhances transparency and consistency, leading to improved completeness of submissions and more efficient pre-market reviews by the FDA.
How to submit an eSTAR
Accessing the CDRH portal: The Center for Devices and Radiological Health (CDRH) serves as the primary platform for online submission or the Electronic Submission Gateway (ESG) for the Center for Biologics Evaluation and Research (CBER).
As of October 1, 2023, all 510(k) submissions must be filed electronically using eSTAR unless exempted. While mandatory for 510(k)s, eSTAR can also be voluntarily used for De Novo requests and Q-submissions (Pre-Sub).
The use of eSTAR is currently voluntary for submission types other than 510(k), but after October 1, 2023, any 510(k)s must be submitted electronically using eSTAR. The final guidance for De Novo Requests sets an implementation date of October 1, 2025, after which De Novo submissions must use eSTAR unless exempted. eSTAR usage is still voluntary until October 1, 2025.
Alternate submission methods: Manufacturers may also submit an electronic copy via the mail.
Conclusion
The FDA eSTAR platform represents a transformative advancement in the medical device field, offering manufacturers a structured and efficient regulatory standard. By leveraging eSTARs automated check, integrated guidance companies can error submission errors, enhance data clarity, and improve the chances of timely FDA approval. Adopting eSTAR aligns manufacturers with best practices in regulatory compliance and accelerates patient access to innovative medical technologies.
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