FDA and Health Canada eSTAR Pilot is Open and Accepting Participant Requests

A joint eSTAR pilot (which we previewed in November) between FDA and Health Canada has now been launched. This pilot program will test the use of a single eSTAR application submitted to both regulatory bodies.

For those unfamiliar or needing a refresher, eSTAR is an interactive PDF template that:

• allows for form construction and autofill,
• complements internal review templates used at CDRH,
• harmonizes with the Non-In Vitro Diagnostic Device Market Authorization Table of Contents used by the International Medical Devices Regulators Forum (IMDRF),
• integrates with resources such as guidance documents and databases,
• guides construction for each section of the submission, and
• checks for incomplete sections.

To participate, device sponsors must send an email to both eSubPilot@fda.hhs.gov and meddevices-instrumentsmed@hc-sc.gc.ca with the subject line “Request for participation in eSTAR Pilot.”  The request email should include basic information, such as applicant name and device trade name, as well as the FDA primary product code, Global Medical Device Nomenclature (GMDN) and Preferred Name Code (PNC) of the device. Additionally, the request should include a statement that the same medical device under eSTAR will be submitted to FDA and Health Canada within 6 months of acceptance of the pilot program:

• For FDA, specify if it is a 510(k), De Novo, or pre-market approval (PMA) original, 180-day, real-time or panel track supplement to FDA; and
• For Health Canada, specify if it represents a new or significant change amendment Class III or IV submission to Health Canada.

Responses from FDA and Health Canada to interested sponsors are expected within 3 business days of the email request. Nine participants will be selected to use the non-In Vitro Diagnostic eSTAR.

Sponsors with combination products, in vitro diagnostic devices, CBER-led products, or FDA dual 510(k)/CLIA waiver application are ineligible for participation in the pilot program.

This pilot program is one example of how CDRH is implementing policies and programs that promote international regulatory alignment. If a device sponsor is actively pursuing marketing authorization in the US and Canada, this has the potential to save time on preparing two separate applications.

It is worth noting that user fees must still be paid to FDA and Health Canada, and review timelines remain the same as they do for non-pilot submissions.

While the initial information provided in eSTAR to FDA and Health Canada is identical, responses to any requests for additional information must be handled separately for FDA and Health Canada. For 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. It remains to be seen how aligned the final scope of the marketing authorizations will be and how much regulatory burden is actually reduced.