FDA periodically starts pilot programs in order to help improve coherence and efficiency in procedure 510 (k). Those programs are intended to help both industry and FDA staff to use the resources effectively.
eSTAR pilot program (electronic Submission Template And Resource) is a template of electronic sending in PDF, offered by FDA that guides the participants selected in the pilot project to prepare 510 (k).

FDA starts eSTAR pilot program for procedure 510 (k) Medical Devices
FDA starts eSTAR pilot program for procedure 510 (k)

Advantages of the eSTAR pilot program

The eSTAR pilot program includes benefits similar to the eSubmitter program, like: automation, content and structure complementary to CDRH internal audit models, integration of more resources, guided construction for each presentation section, automatic verification, free of charge.

eSTAR additional advantages are: more intuitive interface, no installation of special software (if the user already has Adobe Acrobat or similar software), support for dynamic pop-up images and messages, mobile device and Apple iOS support, opportunity to comment once converted in static PDF and the ability to share an eSTAR file under construction.

How is eSTAR different from eSubmitter?

eSTAR is designed differently from eSubmitter, because through a collection of questions and instructions that guide the user, it can improve the efficiency with which the Medical Devices industry prepares and sends a 510 (k). Moreover, its functionality and its content are embedded in a PDF that allows the sector greater flexibility during the development, display and modification of a 510 (k).

FDA assesses whether the use of eSTAR produces well-organized submissions, compared to prepared submissions such as eCopy or with the eSubmitter application, to make Medical Devices accessible in a timely, safe and effective way.

The eSTAR pilot program started on February 27, 2020. At the moment, FDA has selected nine participants who provide a general representation of the medical device sector and who satisfy the selection criteria set out in the Notice of the Federal Registry.

For more information see our section FAQ How to register Medical Devices in the world – What is the 510 (k)? and contact us at sales@thema-med.com to know Thema services on the extra-EU international registrations.