This year the US FDA and Health Canada are piloting the so-called eSTAR submission together. The eSTAR is an interactive medical device submission process, which allows the applicant to use an online system to submit the medical device application. The eSTAR also improves the FDA’s review work and has an auto-identity system that can easily classify files.

The eSTAR features can be summarized as follows [1]:

● Automation (for example, form construction and autofill)

● Content and structure that is complementary to the CDRH internal review templates.

● Integration of multiple resources (for example, guidance and databases)

● Guided construction for each submission section

● Automatic verification

The main purpose of eSTAR is that it is intended to enhance the incoming quality of submissions. It can improve the applicant's familiarity with the FDA submission file requirements and thus reduces the reviewer's work.

At this point in time, all medical device submitters for 510(k)s and De Novos may voluntarily use eSTAR to submit to CDRH free of charge. However, combination products are not allowed to utilize the eSTAR submission. As the US FDA is piloting eSTAR submissions jointly with Health Canada, it is definitely encouraged to complete medical device registration via this new path.



Voluntary eSTAR Program
Health Canada and FDA eSTAR Pilot