Emergo by UL Presents on the U.S. FDA eSTAR at Korea’s KIMES 2024

By Catherine (Kyunghyun) Yeo

Many medical device manufacturers, importers and service providers exhibited their latest products at Korea’s KIMES 2024, in Seoul from March 14 through March 17. We at Emergo by UL spoke at KIMES 2024 to reveal regulatory tips, including an overview of the current U.S. eSTAR template for submitting 510(k)s or De Novo reclassification applications to the U.S. Food and Drug Administration (FDA) and how to manage expiring notified body certificates under the European medical device Directives.

Read on for a synopsis of our presentation on the U.S. FDA eSTAR program.

Are you ready to submit with eSTAR?

The U.S. FDA has transformed the process for medical device applicants by introducing Electronic Submission Templates and Resources (eSTAR). The eSTAR template aims to improve submission quality by facilitating comprehensive data submission in a standardized format. Since October 1, 2023, the use of eSTAR for electronic submission has become mandatory for all premarket notifications (510(k)), unless exempted. Therefore, medical device manufacturers who intend to submit a 510(k) to the FDA and have no prior experience with eSTAR must now familiarize themselves with this system.  Additionally, if you are unfamiliar with the FDA's requirements, navigating the complex landscape of U.S. medical device regulation can be difficult. Manufacturers are advised to seek professional assistance from a regulatory affairs consultant, as a rejected application may result in delays in market entry.

Use of eSTAR for 510(k) and De Novo submissions

eSTAR is a new interactive electronic submission template that guides medical device manufacturers through the process of preparing a 510(k) application. The introduction of this submission tool represents a significant step forward for the FDA in enhancing and simplifying the regulatory review process for medical devices. This new electronic template offers several benefits to manufacturers, including reduced administrative burden, faster review timelines and improved communication with regulators. Nevertheless, adapting your approach to prepare a 510(k) under the new eSTAR requirements is no simple task.

For manufacturers to successfully implement the template, they will need to adapt internal processes and systems to the new electronic submission requirements, including training employees to use eSTAR and confirming compliance with regulatory standards for electronic submission.  As eSTAR is required for 510(k)s, manufacturers should familiarize themselves with eSTAR and its capabilities. However, for other types of premarket submissions, such as De Novo requests and PMAs, the use of eSTAR is optional and can be used voluntarily.

What are the main features of the eSTAR template?

Key eSTAR features include:

• eSTAR is an interactive PDF file comprising a comprehensive “collection of questions, text, logic, and prompts”, crafted to guide manufacturers in compiling the 510(k) submission.  
• eSTAR includes specific integrated forms (Form 3514, Form 3881, The truthful and accurate statement) so manufacturers do not need to complete them separately.
• eSTAR allows electronic submissions through the FDA's portal or gateway.
• The eSTAR template allows for attaching various files, including documents, images, and videos, to support your submission.
• FDA does not conduct an acceptance review of eSTAR submissions but instead performs a viral testing and technical review process.
• eSTAR assists applicants in creating comprehensive submissions that include all essential elements required for FDA review.

Valuable tips for a successful application

• While using eSTAR, it is important to note that it does not replace the need for compliance with regulations, guidelines, and standards that apply to your device. Manufacturers must identify and comply with the regulations, guidance and standards applicable to their devices and must provide appropriate and valid scientific evidence to support their submissions.
• Prepare submission content outside of eSTAR before populating the template.
• To support the proper functionality of eSTAR, Adobe Acrobat Pro is necessary. If you encounter issues such as slow performance or unresponsiveness, you can use alternative software such as FoxIT PDF Reader.
• eSTAR is updated to reflect changed FDA-related policies. Manufacturers should confirm that their eSTAR submission uses the most current version before submitting it to the FDA. To confirm compliance with the latest policies and standards, eSTAR undergoes periodic updates by the FDA to address and incorporate changes in regulatory requirements. It is advisable to download the most recent version of eSTAR from the FDA's official website and utilize it for your submission. Additionally, check the FDA's website regularly for any announcements or guidance about eSTAR.
• The total size of eSTAR submissions accepted on the CDRH Portal is limited to 4 GB, with each attachment limited to 1 GB.
• Compressed (zip), macro-enable (dcom), and executable (exe) files are not accepted.
• 510(k) summaries can be automated, but caution should be exercised, as any confidential information entered into text boxes may potentially be summarized as well.

Concluding remarks

This is our fourth article in this series on South Korea. Our first Regulatory Update was a primer on the medical device regulatory system in South Korea. In the second Insight, we shared observations on how to prepare for a TPA/MFDS K-GMP audit. And, our third Regulatory Update discussed how the MFDS would use MDSAP Audit results instead of an on-site audit for K-GMP.