eSTAR: A New Way to Submit 510(k) Submissions Electronically

 

 

If you are a medical device manufacturer who plans to submit a premarket notification (510(k)) to the FDA, you may want to know about eSTAR, a new electronic submission template that became mandatory on October 1, 2023.
eSTAR stands for electronic Submission Template And Resource, and it is a guided tool that helps you prepare a complete and well-organised 510(k) submission in an electronic format.

 

What is eSTAR?

eSTAR is a dynamic PDF file containing a collection of questions, text, logic, and prompts that guide you through constructing a 510(k) submission. eSTAR is highly automated, integrated with multiple resources (e.g., FDA product codes, FDA-recognised voluntary consensus standards), and structured to follow the content of the internal review templates used by FDA reviewers. eSTAR also includes links to relevant regulations, guidances, and other resources for your reference. eSTAR is free to download and use from the FDA's website.

 

What are the benefits of eSTAR?

eSTAR offers several benefits for submitters and reviewers of 510(k) submissions. Some of the benefits are:

 

• eSTAR helps you create a complete submission containing all the elements required by regulation or essential for the FDA's review. eSTAR also verifies that your submission is complete before you submit it to FDA.
• eSTAR helps you organise your submission in a consistent and clear way that facilitates the FDA's review process and enhances efficiency. eSTAR also allows you to add attachments, such as documents, images, and videos, that support your submission.
• eSTAR helps you avoid common errors and deficiencies that may delay your submission review or result in a refuse to accept (RTA) decision. eSTAR also provides feedback and tips on improving your submission quality and content.
• eSTAR helps you save time and resources by eliminating the need to print and mail paper copies of your submission. eSTAR also allows you to submit your submission electronically via the FDA's portal or gateway.

What should you keep in mind when using eSTAR?

While eSTAR is designed to be user-friendly and intuitive, there are some things that you should keep in mind when using it. Some of the tips are:

 

• eSTAR requires Adobe Acrobat Pro to run properly. You should ensure that you have the latest version of the software installed on your computer and the necessary permissions to use it.

• The eSTAR PDF can be slow/unresponsive due to a bug in Adobe Acrobat Pro. The FDA is collaborating with Adobe to fix the problem. Users facing issues can use alternative software like FoxIT PDF Reader or PDF-XChange Editor.

 

• eSTAR currently lacks the capability for change control and tracking changes, making it challenging to discern edits within 510(k) submissions. Historically, these submissions involve collaboration among a team of individuals from both product development and regulatory functions. To mitigate potential issues arising from the absence of tracked changes in the eSTAR form, it is advisable to designate a single person responsible for compiling and updating the document.

• eSTAR is updated periodically to reflect the latest policies and standards. You should always download the most recent version of eSTAR from the FDA's website and use it for your submission. You should also check the FDA's website for any announcements or guidance related to eSTAR.
• eSTAR is not a substitute for following the applicable regulations, guidances, and standards for your device. You should always consult the relevant sources of information and ensure that your submission meets the statutory and regulatory criteria for substantial equivalence.
• eSTAR is not a guarantee of a favourable review outcome. You are still responsible for providing adequate and valid scientific evidence to support your submission and demonstrate that your device is safe and effective for its intended use.

What happens if you do not use eSTAR?

As mentioned, eSTAR is mandatory for all 510(k) submissions, including original submissions, supplements, and amendments, unless exempt, starting from October 1, 2023. If you do not use eSTAR for your submission, the FDA will not receive your submission unless you have an exemption or a waiver. FDA has not identified any circumstances appropriate for a waiver and does not intend to grant requests for waiver. The FDA has also identified limited exemptions, such as interactive review responses, appeals, and withdrawal requests, listed in the guidance document. If your submission does not fall under exemptions, you must use eSTAR to submit your 510(k).

 

Recently, the US FDA announced the voluntary use of eSTAR for Pre-Market Approvals (PMAs). Check the update by clicking here.

 

In Summary:

 

eSTAR is a new electronic submission template that will help you prepare a complete and well-organised 510(k) submission in electronic format. eSTAR offers several benefits for both submitters and reviewers, such as improving submission quality, consistency, and efficiency. Unless exempted, eSTAR  has been required for all 510(k) submissions since October 1, 2023. You should familiarise yourself with eSTAR and its features, and download the latest version from the FDA's website. You should also follow the applicable regulations, guidances, and standards for your device and provide adequate and valid scientific evidence to support your submission. By using eSTAR, you will be able to submit your 510(k) electronically and facilitate FDA's review process.

 

Experts at Med-Di-Dia can support your US FDA submission by managing the process on an ad hoc or end-to-end basis. Our specialists can devise the right roadmap for your medical device.

 

Get access to our expertise and services by sending an email – mdd@mddltd.com or by submitting this webform - https://mailchi.mp/5e723d5d0162/eg0l6ij7y9

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