Dive Brief:

• FDA has shared additional instructions and clarifications about the eSTAR process for 510(k) filing as part of an update to its advice on premarket submissions.
• The two updated eSTAR templates for in vitro diagnostics and other medical devices feature minor changes to the older texts for 510(k) filings, enabling medtech companies to continue to use the previous versions for any submissions that are already at the draft stage. 
• FDA used the update to expand eSTAR to De Novo medical device and IVD applications. The agency will start accepting De Novo eSTAR applications when a final rule takes effect at the start of next year.

Dive Insight:

FDA began an eSTAR pilot program last year to try to improve the consistency of 510(k) filings. The template follows the same structure, and covers the same content, as resources the agency already uses internally. FDA framed the consistency with internal resources as a way to improve the efficiency of 510(k) assessments.

Since setting out to enroll up to nine participants in the pilot program last year, FDA has made several rounds of updates to eSTAR. The latest update sees eSTAR graduate to Version 1.0, although the new text hews closely to earlier iterations. 

The similarity of the latest text to its predecessors will ease the transition. While FDA wants companies to use the latest text for all new submissions, it will continue to accept 510(k) filings that are based on older versions of eSTAR that are already at the draft stage. FDA cited nIVD eSTAR Version 0.7 and IVD eSTAR Version 0.3 as iterations that remain valid.

Both the IVD and medical device eSTAR templates now cover De Novo applications, moving the program beyond 510(k) submissions for the first time. FDA has made the templates available to allow manufacturers to familiarize themselves with the content and compile De Novo requests. However, FDA is asking manufacturers not to use eSTAR for submissions made before Jan. 3, 2022.

The start date for the acceptance of eSTAR De Novo submissions is aligned with a final rule published last month. The final rule, which establishes requirements for the De Novo classification process, will take effect at the beginning of next year.

FDA linked to the new eSTAR information from its updated premarket submission page. The agency has reworked the page, the old version of which featured eight links split up into the categories Cross Cutting, Approvals & Clearances and Resources. None of the links on the old page went to the eSTAR information. 

Now, the premarket submission page is designed to help manufacturers select and prepare the correct submission. The page features links to all types of premarket submission, information about support for premarket submissions, details of user fees, as well as advice on how to prepare, send and track filings. The eSTAR link is in the section on preparing, sending, and tracking submissions.