Do you remember the FDA eSubmitter?
Over the years, the FDA has had several 510(k) submission programs to make the process more streamlined and effective. This was achieved by going from paper systems to e-copies, e–submitter and Electronic Submission Gateways (ESG). In 2021, eSubmitter was discontinued after the eSTAR Pilot Program was launched in 2020. So far, eSTAR has been voluntary […]