Published 2023
Encore: We hope you enjoyed the eSTAR series and are actively using the eSTAR templates to prepare your 510(k) or De Novo submissions, and now Pre-Subs (“PreSTARs”). As the eSTAR program continues to evolve, please check the Encores of this Client Alert series for updates on the eSTAR program.
The eSTAR and I - Encore #1
In Rodgers and Hammerstein’s Broadway hit The King and I, set in the 1860’s, the King was fascinated with science and innovation. He hired a schoolteacher, Anna, to be a governess to his children and educate them, to help modernize the country. In our adaptation, set in 2022, the King (FDA) implemented the voluntary eSTAR program to help modernize (and standardize) 510(k) and De Novo submissions. This submission format becomes mandatory starting October 1, 2023, for new 510(k) submissions in the kingdom. To help you gain experience and fully leverage this new submission format, we have created a four-part Client Series in tune with lyrics of the popular song from this musical “Getting to Know You”:Encore: We hope you enjoyed the eSTAR series and are actively using the eSTAR templates to prepare your 510(k) or De Novo submissions, and now Pre-Subs (“PreSTARs”). As the eSTAR program continues to evolve, please check the Encores of this Client Alert series for updates on the eSTAR program.