The U.S. Food & Drug Administration (FDA) and Health Canada has announced a joint pilot program to test the feasibility of using eSTAR to prepare a single medical device submission to both Health Canada and the FDA for premarket approval.
The practicability of using eSTAR will be determined by the outcome of 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).
What is eSTAR?
eSTAR (electronic Submission Template and Resource) an interactive PDF form that provides assistance to applicants through the process of preparing a comprehensive medical device submission like 510(k)s and De Novos submitted to CDRH. It is free and available for voluntary use to all medical device submitters. The template has the following Features
- Automation (form construction and autofill)
- Guided construction for each submission section
- Integration of multiple resources (guidance documents and databases)
- Content and structure that match the internal review templates used by Center for Devices and Radiological Health (CDRH) and also harmonized with the IMDRF’s Non-in vitro Diagnostic Device Market Authorization Table of Contents document.
- Automatic verification feature.
Eligibility factors and participation requirements for the eSTAR pilot
The Eligibility of Device Sponsors to participate in pilot
- The Sponsor must be ready to submit an eSTAR application for the same medical device in Health Canada and US FDA within 6 months of acceptance into the pilot.
- The submission must be for a new or significant change amendment to Class III or IV submission of Health Canada
- A 510(k), De Novo or Pre-market Approval (PMA) original, 180-day, real-time or panel track supplement to FDA
- The Sponsors must complete the eSTAR application
- The pilot program is NOT applicable to IVD devices, Combination products, CBER products or an FDA dual 510(k)/CLIA waiver application.
The limitations for the eSTAR pilot
- FDA and Health Canada will not accept Regulatory Enrollment Process (REP) submission
- At present eSTAR Submissions are accepted only in English and at later time French language will be accepted for submissions to Health Canada only
Requesting participation in the eSTAR pilot
Interested device sponsors can request participation in pilot by sending email to meddevices-instrumentsmed@hc-sc.gc.ca and eSubPilot@fda.hhs.gov with the subject line “Request for participation in eSTAR Pilot”. The body of the email should include:
- A statement asking to participate
- 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 device
- A statement that the medical device will be submitted within six (6) months of acceptance in the eSTAR pilot to both Health Canada (specify if new or significant change amendment for a Class III or IV) and the FDA (specify if 510(k), De Novo or PMA submission [specify further if original, 180-day, real-time or a panel track supplement]).
The agencies will respond to the request within three (3) business days.
Preparing a submission using eSTAR
If Accepted into joint eSTAR pilot the agencies will provide an information package on preparing submission and the process. The agencies recommend that the eSTAR be under 1 GB in size and any media files like images and videos are need to be compressed (but viewable). To keep file size down, the agencies request attachments of similar content to be combined in a pdf and for bookmarks or a table of contents to be included.
Submitting responses to requests for additional information
If the agencies request additional information in the review of the submission, the response will be in eSTAR for FDA but for Health Canada it is not within the scope of the pilot and information should be submitted as per instructions request from Health Canada.
User fees and Review timeline for eSTAR Pilot
Fees and review timelines are the same as a standard submission.
Health Canada is also running a separate eSTAR pilot for Health Canada-only submissions, and will select 10 applicants. Many of the requirements mirror the combined pilot. To learn more about this separate pilot program, the user can visit the same website linked above for Health Canada.
Note
- The eSTAR is not currently for use with combination products.
- As the Health Canada and U.S. Food and Drug Administration’s joint eSTAR pilot has reached its total of 9 participants. Requests to participate in the pilot are no longer being accepted and the pilot is closed on 27 January 2023
