Now you can upload an FDA eSTAR or eCopy using the FDA Customer Collaboration Portal (CCP)

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. Last week, on July 19, the FDA emailed all active FDA CCP account holders that they can upload both FDA eCopy and FDA eSTAR files to the portal 100% electronically. Since our 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).

FDA CCP Blog ➤ https://medicaldeviceacademy.com/fda-...
eCopy Guidance Blog ➤ https://medicaldeviceacademy.com/ecop...
FDA eCopy Webinar ➤ https://medicaldeviceacademy.com/fda-...
FDA eSTAR Blog ➤ https://medicaldeviceacademy.com/esta...

Timestamps
0:00 Our last FedEx to the FDA
1:22 February 2018 FDA eCopy Process
2:07 July 2022 FDA eCopy Process
3:21 February 2018 510(k) Process
4:10 July 2022 510(k) Process
5:40 Confirmation of Successful Upload
6:32 Do you need help with your eCopy?