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# FDA, Health Canada Open eSTAR Pilot
- URL: https://www.fdaweb.com/fda-health-canada-open-estar-pilot/
- Published: 2023-01-10T12:00:00.000Z
- Updated: 2026-09-14T18:11:18.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153506

FDA says it is partnering with Health Canada on an eSTAR pilot to test the use of a single eSTAR submitted to both agencies. An FDA [notice](https://www.fda.gov/medical-devices/how-study-and-market-your-device/health-canada-and-fda-estar-pilot?utm%5Fmedium=email&utm%5Fsource=govdelivery) describes eSTAR as an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission. It says eSTAR is free and available for voluntary use to all medical device submitters for 510(k)s and *de novos* submitted to CDRH.

“The feasibility of eSTAR will be determined by the outcome of a pilot with nine participants,” the notice says. These are the eligibility factors for the pilot:

- must be ready to submit an eSTAR for the same medical device within six months of pilot acceptance to both Health Canada and FDA for:
  - a new or significant change amendment Class 3 or 4 submission to Health Canada, and
  - a 510(k), *de novo*, or pre-market approval original, 180-day, real-time or panel track supplement to FDA;
- must complete the eSTAR; and
- 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.