eSTAR: What You Need to Know

As of October 2023, 510k submissions MUST be submitted via eSTAR, And while it has made some portions of the submission process easier, there are still some tips and tricks you need to know to make your eSTAR submission work.
Keywords: medical devices, FDA 510 k process, medical device regulatory affairs, FDA 501 k, medical device regulation, FDA 510(k), FDA 510k clearance, regulatory affairs, FDA 510k approvals, regulatory affairs medical devices, FDA pre submission, regulatory compliance, FDA submission, FDA 510k submission guidance

[@jingwan-mc8yf]

COOL