The U.S. Food and Drug Administration (FDA) announced the issuance of its final guidance document for its template for electronic 510(k) submissions on September 22, 2022.

The electronic Submission Template and Resource (eSTAR) electronic submissions template is a monumental accomplishment for FDA’s Center for Devices and Radiological Health (CDRH). Namely, because it creates the first all-electronic means of preparing and submitting a premarket notification 510(k) online. CDRH will accept eSTAR submissions through its Customer Collaboration Portal, also known as the CDRH Portal.

Prior to eSTAR

Previously, CDRH would accept electronic premarket submissions in its eCopy format. However, submitters had to mail the submission on a CD or thumb drive with a hardcopy cover letter. Now, in an expansion of its eSTAR pilot program, FDA established the eSTAR PDF form as the future of electronic 510(k) submissions. Currently, eSTAR is a voluntary submission option. However, as of October 1, 2023, it will be the only mechanism for submitting a 510(k).

eSTAR Highlights

The structure and content of the eSTAR template interface directly with internal CDRH review templates. It facilitates reviews with automation and integration of multiple resources like guidance documents. In addition, each section of the form has instructions and automatic content verification.

Anyone can register for a CDRH Portal account, and eSTAR is free to use for applicants who submit 510(k) or De Novo requests to CDRH or CBER. However, it cannot yet be used with combination products.

Higher Quality Submissions

FDA expects that eSTAR will yield higher quality submissions with relevant, comprehensive data to make its premarket reviews more efficient. This should expedite review times, in part because FDA will not have a Refuse to Accept (RTA) review for eStar submissions. However, in cases of an incomplete eSTAR submission FDA will notify the submitter via email with an explanation of the deficiency. The submission will then be placed on a hold for 180 days or until a complete submission is received.