FDA Teams With Health Canada on eSTAR Pilot

The FDA is partnering with Health Canada to test the FDA’s eSTAR online portal for medical device submissions to the FDA and Health Canada.

The interactive eSTAR form guides applicants through the process of preparing a 510(k) or de novo medical device submission for the FDA, verifying information and completing some fields using autofill.

The two agencies are now inviting applications for nine available slots for the pilot. Device sponsors must be ready to submit applications for their candidate device within six months of acceptance into the program and pay the standard FDA and Health Canada user fees.

The submission must be for a new device application or significant change amendment to Health Canada and a 510(k), de novo or pre-market approval application to the FDA. The pilot will not include in vitro diagnostics or combination products.