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FDA, Health Canada Will Pilot Joint Medical Device Submissions
The joint pilot will test the use of a single eSTAR, an interactive form that guides applicants through the process of preparing FDA medical device submissions.
The FDA and Health Canada (HC) announced a joint pilot to test the use of a single eSTAR to both agencies. The eSTAR is an interactive form that guides applicants through the process of preparing FDA medical device submissions.
The pilot will test the use of a single eSTAR submitted for HC’s Class III and Class IV and FDA’s 510(k), De Novo and Premarket Approval (PMA). In-Vitro Diagnostics, combination products, CBER-led devices, and FDA dual 510(k)/CLIA Waiver applications are not included within the scope of this pilot.
The feasibility of using eSTAR will be determined by the outcome of a pilot with nine participants using 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). Additional details, including how to Request to Participate, are described on FDA's webpage. Applications for the pilot are now being accepted.
