FDA will Accept 510k Submissions Only Electronically
(Thursday, September 22, 2022)
Starting next year, FDA would stop accepting 510k applications as paper submissions or even as an eCopy loaded on to a DVD or a flash drive. The only acceptable format for submission of an electronic 510k applications would be those created using the eSTAR template released earlier this year. While electronic submission of clinical trial and market approval applications for drugs and biologics have been mandatory for the last few years, medical device applications still are submitted to the FDA as conventional paper submissions or a hybrid format via the eCopy program. Both the paper submissions and the eCopy versions are cumbersome and antiquated methods. While the drug and biologics applications have globally accepted formats with practically all countries in the World requiring the electronic common technical document (eCTD) format, medical devices are regulated very differently in the US compared to any other country. Hence, there is no universal global format for market approval applications for medical devices. So, FDA had to go at it alone and create its own tools. FDA has been at work for several years to create a reasonable electronic submission format. First, it was the eCopy program, then it was a e-Submitter pilot software, and now the eSTAR interactive PDF, released earlier this year. In a new guidance document released this week, FDA adds on to the previously available information on the eSTAR PDF describing the terminology and explaining the various sections of the template. The most important part of the guidance is the announcement that the eSTAR is the final version for 510k applications and starting 23 October 2023, it will be mandatory and FDA will not accept traditional paper 510k submissions. There would be no waiver or exceptions to this requirement for new 510k applications. As we discussed in our earlier post, using the eSTAR PDF will make the process of 510k submissions simple and streamlined. FDA predicts that this would also minimize the Refuse to File (RTF) events and expedite the 510k review and clearance since the eSTAR has built in logic checks based on the 510k checklists. The electronic 510k applications would make everyone’s life easy with regards to submission of the most common medical device application to the FDA. Amen to that.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC