- 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)
eSTAR is free and available for voluntary use to all medical device submitters for 510(k)s and De Novos submitted 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 to 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). Request for participation in the pilot is now closed.
Eligibility factors for the eSTAR pilot
To be eligible to participate in this pilot, device sponsors:
- Must be ready to submit an eSTAR for the same medical device within 6 months of pilot 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.
For the joint eSTAR pilot, Health Canada will not be accepting regulatory enrollment process (REP) submissions.
At this time, the FDA and Health Canada are only accepting eSTAR submissions in English. eSTAR submissions in French will follow at a later time for submissions to Health Canada only.
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 participate 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 in the eSTAR pilot 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 within the eSTAR pilot within 3 business days.
Preparing a submission using eSTAR
If you are accepted into the eSTAR pilot, the FDA and Health Canada 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
- The FDA and Health Canada recommend that the eSTAR be 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 from Health Canada.
User fees for eSTAR pilot
eSTAR submissions are subject to 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:
- FDA: DICE@fda.hhs.gov
- Health Canada: meddevices-instrumentsmed@hc-sc.gc.ca
Content current as of:
Regulated Product(s)
- Medical Devices
- Radiation-Emitting Products
