Health Canada and FDA eSTAR pilot: Notice to industry

The Health Canada and U.S. Food and Drug Administration's joint eSTAR pilot is now full, having reached its total of 9 participants. The joint pilot will test the use of a single eSTAR submitted to both the FDA and Health Canada. Note that Health Canada is still accepting participants for the Health Canada-only eSTAR pilot program.

On this page

About eSTAR

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

eSTAR is free and available for voluntary use for all medical device submissions for 510(k)s and De Novos sent to CDRH. The eSTAR is not currently for use with combination products. For more information on the use of eSTAR for premarket submissions, please visit the webpage Voluntary eSTAR Program.

Joint pilot between Health Canada and the FDA

The FDA and Health Canada are conducting a joint pilot. The pilot will test the use of a single eSTAR submitted to both the FDA and Health Canada. The feasibility of using eSTAR will be determined by the outcome of a pilot with 9 participants. Selected participants will use the non-In Vitro Diagnostic eSTAR, which follows the structure of the IMDRF Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nIVD MA ToC).

Health Canada is also launching our own pilot. For information on Health Canada only pilot, please refer to the Health Canada eSTAR pilot program page .

Eligibility factors for the eSTAR pilot

To be eligible to participate in this pilot:

For the joint eSTAR pilot, Health Canada will not be accepting regulatory enrolment process (REP) submissions.

At this time, we are only accepting English eSTAR submissions. French eSTAR submissions will follow at a later time.

Requesting participation in the eSTAR pilot

To request participation in the pilot, send an email to both meddevices-instrumentsmed@hc-sc.gc.ca and eSubPilot@fda.hhs.gov with the subject line "Request for participation in eSTAR Pilot".

Include the following information in your email:

The FDA and Health Canada intend to respond to your request for participation in the eSTAR pilot within 3 business days.

Preparing a submission using eSTAR

If you are accepted into the eSTAR pilot, the FDA will provide you with an information package that includes:

Please note the following constraints regarding the size and count of attachments added to eSTAR.

File size

File count

Submitting responses to requests for additional information

For FDA

Revise your original eSTAR and indicate in the "Application/Submission Type" section of the eSTAR that the Application Sub-Type is a response to a request for additional information.

After you indicate the intent to provide a response to a request for additional information from the FDA, an additional section will appear near the end of the eSTAR. In this section, you can provide responses to requests for additional information.

For Health Canada

Responses to additional information requests are not within the scope of this pilot and should be submitted as per the instructions on the request.

User fees for eSTAR pilot

eSTAR submissions are subject to user fees.

FDA user fees:

Health Canada user fees:

Review timeline for eSTAR

The review timelines will remain the same as they are for non-pilot submissions.

Contact information

For malfunctions or errors in the eSTAR, please email: eSubPilot@fda.hhs.gov.

For regulatory process or content questions, please email:

Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: