eSTAR and Pre Market Approval

 

 

On 6th December 2023, the USFDA announced the voluntary use of eSTAR -  Electronic Submission Template.

 

Manufacturers can voluntarily use eSTAR while making the following Premarket Approval Applications (PMAs):

• Original PMAs
• PMA Panel Track Supplements (PTS)
• PMA Real-Time (RT) Supplements
• PMA 180-Day Supplements

It must be noted that - All 510(k) submissions, unless exempted, must be submitted as electronic submissions using eSTAR as of 1st October 2023, as pointed out in the final guidance: Electronic Submission Template for Medical Device 510(k) Submissions.

 

Let us understand the eSTAR Program and how it streamlines medical device submissions.

 

The eSTAR program provides a standardised electronic format for submitting premarket applications for medical devices to the FDA. It's essentially a digital template that helps manufacturers organise and present their data in a clear and consistent way.

 

Importance of eSTAR:

• Efficiency: eSTAR saves time and resources for both manufacturers and the FDA. By using a standardised format, manufacturers can be sure they're including all the necessary information, and the FDA can review submissions more quickly and efficiently. This can ultimately lead to faster market access for safe and effective medical devices.
• Accuracy: eSTAR helps to ensure that all the required information is submitted in a complete and accurate way. This reduces the risk of errors and omissions, which can delay the review process or even lead to rejection of the application.
• Transparency: eSTAR makes the submission process more transparent for both manufacturers and the public. The standardised format makes it easier for everyone to understand the information that is being submitted.

 

Key points for Medical Device Manufacturers to note before they begin with eSTAR:

• Use the eSTAR template: All manufacturers submitting 510(k) premarket notifications to the FDA are required to use the eSTAR template. The template is also available for voluntary use with other types of premarket submissions, such as De Novo requests and PMAs.
• Follow the eSTAR guidance documents: The FDA provides detailed guidance documents on how to use the eSTAR template and prepare eSTAR submissions. These documents are essential for ensuring that your submission is complete and accurate.
• Seek help if needed: The FDA offers a variety of resources to help manufacturers with the eSTAR program, including training webinars and technical assistance. Yet, it would be advisable for manufacturers to seek professional support from Regulatory Affairs consultants as rejection of the application can delay the market entry.
• Remember: Using the eSTAR program can help you bring your medical device to market faster and more efficiently. By following the FDA's guidance and using the available resources, you can ensure that your eSTAR submission is complete and accurate, increasing your chances of approval.

 

How Med-Di-Dia Can Help?

Our team at Med-Di-Dia is equipped with the knowledge and expertise to guide you through the eSTAR submission process. We understand the intricacies of the form and can help ensure your submission is complete, accurate, and compliant with FDA requirements.

 

But our support doesn’t stop at eSTAR submissions. We can effectively manage all other US FDA regulatory submissions for medical devices. Whether it’s a 510(k) submission, a De Novo submission, or a Dual 510(k)/CLIA Waiver IVD submission, our team is ready to assist.

 

Drop us an email at mdd@mddltd.com or fill out this webform - https://mailchi.mp/5e723d5d0162/eg0l6ij7y9

 

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