Recently, Health Canada announced two pilot programs for eSTAR, an interactive PDF form that guides an applicant through the process of preparing a medical device submission for regulatory approval before bringing the device to market1.

One pilot is a joint program with the U.S. Food & Drug Administration (FDA) that will be testing the feasibility of using eSTAR to prepare a single medical device submission to both Health Canada and the FDA for premarket approval (the Joint Pilot). The other pilot is a Health Canada-only pilot program assessing the use of eSTAR for medical device submissions to Health Canada only (the Health Canada Pilot).

What you need to know

  • Limited spots are available.The Joint Pilot only accepted nine applicants and is now full, but the Health Canada Pilot, which is selecting 10 applicants, is still accepting applicants. Interested medical device sponsors should submit a request to participate in the Health Canada Pilot as soon as possible.
  • Only certain medical device submissions are eligible. At this time, both pilot programs are only for Class III or IV submissions (for either new submissions or significant change amendments) in English to Health Canada2.
    • Additionally, the following types of Health Canada submissions are not eligible to participate in the pilots: (i) in-vitro diagnostic device submissions; (ii) combination product submissions; and (iii) regulatory enrolment process submissions. For the Joint Pilot, the submission must be a 510(k), De Novo or pre-market approval3 submission to the FDA. Further, the submission must not be for a CBER-led product or dual 510(k)/CLIA waiver application made to the FDA.
  • A successful pilot could mean decreased regulatory burdens for sponsors and faster access to medical devices for Canadians.The standardized format and features of eSTAR help applicants ensure their submissions are complete and are intended to improve submission quality, which should enable Health Canada to review submissions more efficiently4. The introduction of a single eSTAR submission to both Health Canada and the FDA could also result in cost and time savings for medical device sponsors, who will no longer be required to prepare separate applications, reflecting differing requirements, for authorization in each country.

About eSTAR

First developed and piloted by the FDA in February 2020, eSTAR is an interactive template to help guide applicants in their preparation of a medical device submission for premarket authorization that contains the following features:

  • form construction and autofill (i.e., automation);
  • integration with various resources (e.g., guidance documents and databases);
  • guided construction for each section of the submission;
  • automatic verification; and
  • content and structure that is complementary to the FDA Center for Devices and Radiological Health's internal review templates and that is harmonized with the International Medical Devices Regulators Forum'sNon-In Vitro Diagnostic Device Market Authorization Table of Contents document5.

Outside of the Joint Pilot and Health Canada Pilot, eSTAR may currently be used voluntarily for certain medical device submissions6 to the FDA but not to Health Canada. However, the FDA has announced that as of October 1, 2023, the FDA will require all 510(k) submissions, subject to certain exemptions, to be submitted electronically using eSTAR7. Therefore, the potential for adoption of eSTAR by Health Canada following the pilot programs offers potential benefits for device sponsors that market products in both jurisdictions.

How to apply to the Health Canada Pilot

To request participation in the Health Canada Pilot, an email must be sent to [email protected].This email must include:

  • the subject line "Request for participation in eSTAR Pilot - HC only pilot";
  • a statement asking to take part in the Health Canada Pilot;
  • the applicant's name;
  • a contact name and title;
  • the device trade name;
  • the preferred name code (PNC) and global medical device nomenclature (GMDN) of the device;
  • a statement that a Class III or IV eSTAR submission will be sent to Health Canada using eSTAR within 6 months of acceptance to the pilot; and
  • identification of whether the submission is a new submission or significant change amendment.

Health Canada has indicated it will respond to requests for participation in the Health Canada Pilot within 5 business days.

Next steps for pilot participants

If accepted to the Health Canada Pilot program, Health Canada will send an information package and the medical device sponsor will still be required to pay a user fee for its submission.

The timeline for review of the pilot submissions will also remain the same as the timeline for review of non-pilot submissions.

Lastly, only the initial submission will be completed using eSTAR. Submissions of responses to requests for additional information are outside the scope of these pilots. For Health Canada, a response to an additional information request in either pilot program will be required to be submitted per the instructions on the request. For the Joint Pilot, responses to a request for additional information by the FDA will be submitted to the FDA by revising the original eSTAR submission. This means that only the initial submissions to both regulatory authorities will be identical under the Joint Pilot Program. The submission of responses to requests for additional information will be managed differently by each regulatory authority.

Footnotes

  2. Health Canada has indicated that French eSTAR submissions will be accepted at a later time.
  3. Original, 180-day, real-time and panel track submissions are eligible.
  4. For example, see discussion of eSTAR here: United States, U.S. Food & Drug Administration, Voluntary eSTAR Program (11 January 2023), https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program.
  5. United States, U.S. Food & Drug Administration, Voluntary eSTAR Program (11 January 2023), https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program.
  6. eSTAR may currently be used voluntarily for 510(k) and De Novo medical device submissions to the FDA's Center for Devices and Radiological Health and Center for Biologics Evaluation and Research.
  7. United States, U.S. Food & Drug Administration, Voluntary eSTAR Program (11 January 2023), https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.