The FDA is offering the electronic Submission Template And Resource (eSTAR) program for 510(k) and De Novo submissions. Currently electronic submissions through eSTAR are voluntary, however, starting on October 1, 2023, it will be mandatory for all 510(k) submissions to be made electronically unless exempted. Electronic De Novo submissions will remain voluntary until otherwise notified.

DPDC can help you align submissions with eSTAR! Reach out now for a free consultation.

For more information on eSTAR submissions, click here.