FDA eCopy Information

We started the new FDA eCopy service in August 2016 to print and ship 510k submissions to the FDA. In October 2018, the FDA unofficially changed the policy for an FDA eCopy to eliminate the need to print FDA submissions as a hardcopy. Instead, the FDA only requires an FDA eCopy to consist of a USB flash drive and a printed hardcopy of the cover letter. on December 16, 2019, the FDA released a new eCopy guidance that made the unofficial policy official. In July of 2022, the FDA eCopy process was updated again. The FDA created a Customer Collaboration Portal (CCP) for medical device manufacturers. Originally, the portal's purpose was to provide a place where submitters can track the status of their submissions and verify the deadlines for each stage of the submission review process. On July 19, 2022, the FDA emailed all active FDA CPP account holders that they can upload both FDA eCopy and FDA eSTAR files to the portal 100% electronically. Since our FDA 510k consulting team sends out submissions daily, everyone on the team was able to test the new process. If you have a CCP account, you no longer need to ship submissions via FedEx to the Document Control Center (DCC). On October 3, 2022, the FDA also changed the format and content for 510k submissions. The new format and content requirements for a 510k submission involve the FDA eSTAR template. There will be a one-year transition period. All 510k submissions must use the new FDA eSTAR template by October 1, 2023. In preparation for the October 1, 2023 transition deadline, we will be launching a new website: https://fdaestar.com/ this year. The new website will showcase our FDA 510k consulting team and there will be new bios and new videos for everyone on our team.