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The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published detailed guidelines on the electronic Submission Template and Resource (eSTAR) framework introduced to “guide applicants through the process of preparing a comprehensive medical device submission”.
The guidelines published by the FDA provide general information about the relevant regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration in order to ensure compliance thereto.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. Moreover, regarding the FDA guidance documents, the authority explicitly states that an alternative approach could be applied, provided such an approach aligns with the existing legal framework and has been agreed with the authority in advance.
Introduction to eSTAR
The Electronic Submission Template And Resource (eSTAR) represents a transformative approach to medical device submissions to the FDA. It is structured as an interactive PDF form designed to guide applicants through submission.
The primary purpose of eSTAR is to streamline the preparation of comprehensive submissions, ensuring that all necessary information is accurately and fully provided.
Benefits of eSTAR
As further explained by the FDA, eSTAR introduces several advantages aimed at enhancing the submission and review process:
- Guidance for Submitters: This ensures that submitters include all required details, directly aligning with the FDA’s expectations.
- Standardization and Efficiency: By offering a standardized format, it facilitates more accessible access to information for both reviewers and submitters, streamlining the review process.
- Automation: Critical in reducing the need for Refuse to Accept (RTA) reviews, it automates various aspects of submission, ensuring completeness.
- Database Integration: Incorporates databases for device-specific guidance, classification, and standards, improving the accuracy of submissions.
- Comprehensive Resource: Acts as a singular resource for submission preparation, including necessary links and information.
eSTAR Requirements and Usage
According to the guidelines, eSTAR is mandatory for all 510(k) submissions to the Center for Devices and Radiological Health (CDRH) or the Center for Biologics Evaluation and Research (CBER).
While compulsory for these, it remains voluntary for De Novo submissions and other specific submission types, providing certain flexibility for applicants interested in placing their products on the US market.
How to Prepare a Submission Using eSTAR
Preparing a submission involves several steps, beginning with downloading the correct eSTAR PDF template. The process emphasizes understanding the template’s structure, including the Introduction, Key, FAQ, and Version History.
The applicant should also pay attention to file size and attachment requirements, ensuring submissions are within acceptable limits and correctly formatted.
eSTAR Submission Process
Submissions must be channeled through the CDRH Portal or the FDA’s Electronic Submission Gateway (ESG), depending on the center. The built-in features of eSTAR, such as auto-filling information and including necessary forms are intended to streamline the process and simplify submission and review.
MDUFA User Fees and Review Timeline
Submissions via eSTAR are subject to MDUFA user fees, which are contingent on the submission type. The review timeline benefits from the structured format of eSTAR, potentially bypassing the RTA process and facilitating a more straightforward technical review.
Voluntary Nature of eSTAR
As mentioned before, while eSTAR is mandatory for 510(k) submissions post-October 1, 2023, for specific submission types, its use for other submission types remains voluntary since the authority acknowledges the need for certain regulatory flexibility.
Support and Additional Information
The FDA provides additional support for users of eSTAR, including contacts for technical assistance and feedback. The authority provides information on resolving technical issues, such as software bugs, ensuring users can navigate and utilise eSTAR effectively.
Conclusion
In summary, the introduction of the eSTAR framework represents a necessary steps toward a more efficient and convenient submission process to be followed when applying for marketing approval concerning medical devices intended to be marketed and used in the US. The authority has developed detailed guidelines highlighting the key aspects to be taken into consideration by medical device manufacturers and other parties involved to streamline the process and reduce the unneeded regulatory burden.
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