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No More Paper 510k Submissions to the FDA
(Thursday, October 5, 2023) Starting October 1, 2023, FDA no longer accepts paper 510k submissions. As announced before, 510k applications must be created using the eSTAR template and submitted electronically to the FDA for review. This week FDA released the final guidance for the electronic submission of 510k applications, confirming what it proposed about a year ago. Some important things to note about the current rules for electronic 510k applications for applicants. There are no exceptions; every 510k application must use the electronic Submission Template And Resource (eSTAR) submission template which includes a question-based submission tool for creating all kinds of 510k applications, and their submission to the FDA. If you were working on a 510k application on the conventional format, redo it on eSTAR. The eSTAR template allows automation (e.g., form construction, auto-filling) of the application on the content and structure as required by FDA’s internal review templates. It includes embedded resources for 510k-related support such as guidance documents relevant to a given question/topic, and databases for FDA resources such as test methods. The eSTAR also facilitates “guided construction for each submission section and automatic verification of the content and overall application. The eSTAR is based on Adobe Acrobat Pro and is free to use. The eSTAR is not a software that requires installation or training. It allows practically all kinds of documents that may be included in 510k applications such as images and uses all dynamic Adobe Acrobat Pro features. An application created using the eSTAR is almost never expected to receive a Refuse-To-Accept (RTA) outcome because the submission is validated before being submitted to the FDA. The FDA’s final guidance on electronic 510k applications supplements what the FDA has proposed earlier for the eSTAR program. It greatly simplifies the task of creating new 510k applications. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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