The U.S. Food and Drug Administration (FDA) is partnering with Health Canada to launch a joint electronic Submission Template and Resource (eSTAR) pilot.
The joint pilot, announced on January 10th, 2023, will test the feasibility of allowing sponsors to submit medical device submissions to both regulatory bodies through the FDA’s eSTAR online portal. Requests for participating in the pilot are now open to a maximum of nine participants.
About the eSTAR program
eSTAR was launched in 2020 for medical device submissions to the FDA’s Center for Devices and Radiological Health (CDRH). Designed to streamline electronic premarket submissions to FDA for medical devices, eSTAR is a “smart” template that guides applicants through the process of preparing a comprehensive medical device submission using an interactive PDF form. The template contains the following features:
- Automation (e.g., form construction and autofill)
- Guided construction for each submission section
- Integration of multiple resources (e.g., guidances and databases)
- Content and structure are complementary to Center for Devices and Radiological Health (CDRH) internal review templates
- Automatic verification
For the joint pilot, participants will use the non-In Vitro Diagnostic eSTAR, which follows the structure of the International Medical Devices Regulators Forum (IMDRF) Non-In Vitro Diagnostic Device Market Authorization Table of Contents.
eSTAR is free and available for voluntary use for medical device sponsors for both 510(k) and De Novo applications submitted to CDRH. The eSTAR is not currently available for use for combination product submissions. Currently, the FDA and Health Canada are only accepting eSTAR submissions in English; only Health Canada will accept French submissions at a later date.
Joint eSTAR saves applicants time
This pilot program is one example of how CDRH is implementing policies and programs that promote international regulatory alignment. If a medical device sponsor is actively pursuing marketing authorization in the US and Canada, this has the potential to not only save time on preparing two separate applications, but also reduce the barrier to entry into a second market for manufacturers. This could potentially increase the number of sponsors willing to market in Canada.
eSTAR offers another time-saving benefit to manufacturers in that eSTAR submissions avoid the Refuse to Accept process encountered by many manufacturers, particularly those with less experience with FDA submissions. One of the most common reasons that the FDA rejects submissions is due to a lack submission organization. eSTAR provides the framework for submission deliverables so a sponsor can ensure they are providing a complete file. One caveat is applicants must still pay both FDA user fees and Health Canada user fees , and review timelines remain the same as they do for non-pilot submissions.
How to join the pilot
To be eligible to participate in this pilot the following requirements must be met:
- Sponsors must be ready to submit an eSTAR for the same medical device within six 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.
- The eSTAR application must be fully completed (a message at the top of the eSTAR will indicate this).
If you are interested in participating in the pilot, send your request by email to both [email protected] and [email protected] with the subject line “Request for participation in eSTAR Pilot”. You can find the information applicants are required to include in the mail on the joint eSTAR pilot Notice to Industry announcement.
The FDA and Health Canada intend to respond to request for participation within the eSTAR pilot within three business days.
If accepted into the joint eSTAR pilot, the FDA will provide an information package that includes the following:
- 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
You can find additional information on the use of eSTAR for premarket submissions on the FDA’s Voluntary eSTAR Program website.
Health Canada is also launching a separate pilot that will enable medical device manufacturers to submit an eSTAR submission for a new or significant change amendment for a Class III or IV application. For this pilot, 10 participants who meet the criteria will be chosen to participate. More information regarding this pilot can be found on the Health Canada’s eSTAR Pilot Program website.
While the initial information provided in eSTAR to the FDA and Health Canada is identical, responses to any requests for additional information must be handled separately for the FDA and Health Canada. For the FDA, the Application Sub-Type must be revised in eSTAR to reflect a response to a request for additional information. For Health Canada, responses should be submitted per instructions from the regulatory body.
While the use of eSTAR was initially voluntary, sponsors will be required to use eSTAR for the majority of device submissions to the FDA starting October 1, 2023. As a result, the FDA recommends that manufacturers become familiar with using eSTAR over the next few months.
The FDA and Health Canada predict that eSTAR will reduce review time for premarket medical device submissions by standardizing the submission process and improving submission quality. This joint eSTAR pilot will help to showcase how regulatory bodies can align to harmonize processes to the benefit of manufacturers and public health. StarFish Medical will be providing a detailed guide to the eSTAR application process in an upcoming whitepaper.
Alexandra (Sandy) Reid is a StarFish Medical QA/RA specialist. She brings years of experience working in the industry. Sandy supports the QA/RA team in helping clients develop and deliver FDA Approved or Cleared Medical Devices.