Health Canada and FDA eSTAR pilot: Notice to industry

On this page

• About eSTAR
• Joint pilot between Health Canada and the FDA
• Eligibility factors for the eSTAR pilot
• Requesting participation in the eSTAR pilot
• Preparing a submission using eSTAR
• Submitting responses to requests for additional information
• User fees for eSTAR pilot
• Review timeline for eSTAR
• Contact information

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:

• automation (for example, form construction and autofill)
• content and structure that is:
• complementary to Center for Devices and Radiological Health (CDRH) internal review templates
• harmonized with the Non-In Vitro Diagnostic Device Market Authorization Table of Contents document used by the International Medical Devices Regulators Forum (IMDRF)
• integration of multiple resources (for example, guidances and databases)
• guided construction for each submission section
• automatic verification

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:

• You must be ready to submit an eSTAR for the same medical device within 6 months of acceptance to both Health Canada and the FDA for:
  • a new or significant change amendment Class III or IV submission to Health Canada and
  • a 510(k), De Novo or pre-market approval (PMA) original, 180-day, real-time or panel track supplement to the FDA
• The medical device must not be an in-vitro diagnostic device, a combination product, CBER-led or an FDA dual 510(k)/CLIA waiver application.
• You must complete the eSTAR (a message at the top of the eSTAR will indicate this).

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:

• a statement asking to take part in the pilot
• applicant name
• contact name and title
• device trade name(s)
• the FDA primary product code, Global Medical Device Nomenclature (GMDN) and Preferred Name Code (PNC) of your device
• a statement that the same medical device using the eSTAR will be submitted within 6 months of acceptance to both Health Canada and the FDA
• for Health Canada: specify if it is a new or significant change amendment for a Class III or IV submission
• for FDA: specify if it is a 510(k), De Novo or PMA submission (specify if the PMA submission is original, 180-day, real-time or a panel track supplement)

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:

• the eSTAR to use in preparing your submission, with both Health Canada and FDA content enabled
• information regarding the submission process for each jurisdiction, such as:
• internet portal
• mail service

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

File size

• Try to keep the eSTAR under 1 GB in size (may take longer to process the submission if it's larger than this).
• Make sure that attached images and videos are compressed in a Microsoft Windows-compatible format viewable in native Windows OS applications (for example, JPEG, MP4).
• Provide ultra-high-definition videos only if high resolution is necessary to support the review of the device.
• Take care when determining the proper resolution to display features of interest in images and videos.

File count

• Combine attachments of similar content (for example, software requirements specifications) when possible so that only 1 attachment needs to be provided to each attachment type question in the eSTAR.
• Choose "Tools" then "Combine Files" in Adobe Acrobat Pro to combine attachments.
• Use bookmarks or a table of contents for combined documents, to make it easier to review.

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:

• MDUFA user fees

Health Canada user fees:

• Fees for the examination of an application for a medical device licence

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:

• FDA: DICE@fda.hhs.gov
• Health Canada: meddevices-instrumentsmed@hc-sc.gc.ca