On 10th January 2023 the FDA announced a joint eSTAR, the electronic Submission Template And Resource pilot together with Health Canada. This is another approach in digitalisation via harmonising submission formats, allowing originators to reuse data and documents in different regions. The pilot will test the use of a single eSTAR submitted to both the FDA and Health Canada.

What is eSTAR?

eSTAR is an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission. This template contains:

  • Automation (for example, form construction and autofill)
  • Content and structure that is complementary to CDRH internal review templates
  • Integration of multiple resources (for example, guidances and databases)
  • Guided construction for each submission section
  • Automatic verification

Why eSTAR?

It is the intention of the eSTAR pilot to provide regulators with better quality submissions for a wide range of medical devices and help to ensure originators provide quality, comprehensive data, simplifying regulators’ reviews. With a standardised format, originators can make sure that submissions are complete, and hence premarket reviews can be performed more efficiently.

Technical restrictions

  • File size should be under 1GByte
  • Images and videos should be provided in compressed format
  • Ensure one attachment only for each attachment type question
  • Use bookmarks or table of contents for combined documents to ease navigation

In summary

I believe this is an excellent approach from the FDA and Health Canada to allow further harmonisation, thereby moving the entire submission process further to the digital world. A harmonised approach will simplify submissions for the originators and ease review burden for the regulators at the same time. A win-win for all concerned.

Published by Olaf Schoepke

Passionate about sharing ideas with regulatory professionals in the human and veterinary medicinal product space.

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