Last updated: 6 December 2023
See updates at the end of the post.
The FDA has partnered with Health Canada to launch a joint eSTAR pilot.
What is eSTAR?
Electronic Submission Template And Resource or 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 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
What are the benefits of eSTAR?
eSTAR has a range of benefits which include the following:
- Guides the submitter to ensure they provide the necessary details for the submission.
- Complements the reviewers’ internal Submission Memo And Review Template (SMART) used to review the submission (the questions correlate), so the reviewer is getting what is expected.
- Provides a standardized format to make information accessible for the reviewer and submitter.
- Automates many aspects of the submission to ensure the content is present, eliminating the need for a Refuse to Accept (RTA) review by the reviewer and RTA holds. The FDA does not intend to conduct an RTA review for an eSTAR submission.
- Auto fills entered information to avoid entering the same information twice.
You can read about the other benefits of eSTAR on this page.
What medical device applications are in scope for the eSTAR pilot?
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.
What is the aim of the pilot?
The pilot will test the use of a single eSTAR submitted to both the FDA and Health Canada. Requests for participating in the pilot are now open.
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).
What are the 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.
- Must complete the eSTAR (a message at the top of the eSTAR will indicate this).
- 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.
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.
How do you request 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.
How should you prepare 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 that there are constraints regarding the size and count of attachments added to eSTAR and you can find out more on this page under the headings ‘File size’ and ‘file count’
Are there user fees for eSTAR Pilot?
Yes there are and you can obtain further information on fees via links under the heading ‘User fees for eSTAR pilot’ on this page.
What is the review timeline for eSTAR?
The review timelines will remain the same as they are for non-pilot submissions.
Since when has it been possible to send Medical Device eCOPY or eSTAR premarket submissions online to the FDA?
The FDA announced on 23 October 2022 that you may send electronic copy (eCopy) or electronic Submission Template And Resource (eSTAR) premarket submissions online through the CDRH Customer Collaboration Portal (“CDRH Portal”).
When will it become mandatory to submit all 510k submissions (unless exempted) as electronic submissions using eSTAR to the FDA?
Starting 1 October 2023, all 510(k) submissions, unless exempted*, must be submitted as electronic submissions using eSTAR.
Where can you find more information on the use of eSTAR for premarket submissions?
You can find more information on the use of eSTAR for premarket submissions on this page or on this page.
eSTAR now available for voluntary use with certain Premarket Approval Applications
On 6 December 2023, the FDA confirmed the availability of eSTAR for voluntary use for the following Premarket Approval Applications (PMAs) submission types:
- Original PMAs
- PMA Panel Track Supplements (PTS)
- PMA Real-Time (RT) Supplements
- PMA 180-Day Supplements
It has been mandatory since 1 October 2023 to submit all 510(k) submissions (unless exempted) as electronic submissions using eSTAR, as noted in the final guidance: Electronic Submission Template for Medical Device 510(k) Submissions.
Sources: FDA, FDA eSTAR program, Health Canada
Updates
| Date | Update(s) |
|---|---|
| 6 Dec 2023 | The headings What are the benefits of eSTAR? and eSTAR now available for voluntary use with certain Premarket Approval Applications plus relevant content added |