FDA “Voluntary” (For NOW) eSTAR Program

Jun 26, 2023 | White Paper |

You NEED the FDA eSTAR Quick Guide!

Who remembers when Microsoft Office first came out? Everyone was learning and an Excel or Word laminated cheat sheet could be bought at the grocery store to help with the learning curve. This eSTAR White Paper has a similar intent, as a quick reference guide, to give regulatory professionals tips and tricks to confidently take their first steps in navigating the eSTAR template for a 510(k).

MEDIcept suggests not to procrastinate because as of October 1, 2023 all 510(k) submissions, unless exempted, must be submitted as an electronic submission using eSTAR. That’s only a little over 3 months away!

Take this White Paper and use FDA’s resources Voluntary eSTAR Program | FDA to tackle your eSTAR 510(k) drafting!

Click to read the latest MEDIcept White Paper!