Fully Electronic 510k Applications are Coming Soon
(Thursday, September 30, 2021)
The 510k applications are one of the very few regulatory applications that are still submitted as fully or partially paper documents that must be mailed to the FDA offices rather than uploaded to the Electronic Submission Gateway (ESG). This week FDA released a guidance describing its process to transition to electronic 510k applications. The process would initially involve using a PDF template to create the application which will be copied on a CD, DVD or USB drive and mailed to the FDA. In a few years, these applications would be uploaded on to the ESG. Unlike applications for drugs and biologics where the application format has been harmonized world-wide via the Common Technical Document (CTD), for medical device applications FDA had to go alone since the US applications for medical devices are very different from those used in other countries for similar products. The 510k application format is a lot simpler than the CTD. FDA has created a dynamic PDF called eSTAR (electronic Submission Template And Resource) that guides a user via a Q&A format through the various sections of the application to construct an electronic submission. The eSTAR is free to download and only needs Adobe Acrobat to use; no other software or tool needed. The eSTAR consists of a collection of questions, text, logic, and prompts that guides a user through construction of a ‘complete’ 510(k) submission. The Product Codes and Consensus Standards database are integrated with the template, along with links to relevant guidance documents and other resources. The targeted questions included in the template are designed to collect relevant data to be included in the 510k. The dynamic PDF automatically verify the content and such applications will not undergo the refuse-to-accept (RTA) process, but rather a technical review to assure that the eSTAR worked as intended. At this time, eSTAR is optional so sponsors can still file conventional eCopy compliant 510k applications. In one year, on 30 September 2022, FDA will announce the specific date after which only 510k applications created using eSTAR will be accepted. FDA anticipates the date for eSTAR only 510k will be before the end of 2023. The eSTAR is an excellent, free, and easy tool to create 510k applications that should be popular with submitters. There seems to be no excuse to wait till FDA makes it mandatory to use it.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC