What’s new in FDA eSTAR v5.0?

[@maryvater1837]

Thanks for the summary of updates! I am drafting my first v5.0 today.

[@MedicalDeviceAcademy]

I think you will probably be the first on our team. I think the cybersecurity additions are the most important, but I want to spend some time over the holidays performing a deep dive on the PMA submission option.

[@tifanychesser6286]

Thank you for the great information.

[@MedicalDeviceAcademy]

Glad it was helpful! I appreciated all of the feedback people gave me.

[@assassinsylvia8117]

I am curious what exactly is a PMA?

[@MTB_Rider_96]

Pre Market Approval. For High Risk devices that are not eligible for the 510k program.

[@MedicalDeviceAcademy]

As stated in the other comment, the acronym PMA stands for Premarket Approval. This process is limited to class 3 devices. I am publishing a new blog this morning on the FDA eSTAR v5.0. The posting time scheduled is 9:00 am: medicaldeviceacademy.com/fda-estar/. That blog post goes into more detail about PMA submissions and there will be a link for the FDA's webpage dedicated to PMAs: www.fda.gov/medical-devices/premarket-approval-pma/pma-application-methods

[@danielkamm9453]

Version 5.1 came out on January 8

[@MedicalDeviceAcademy]

Thank you. I'll be updating the blog on v5.0 to 5.1 soon.