eSTAR (electronic Submission Template and Resource) is an initiative launched by the US Food and Drug Administration in February 2020. It is a free, interactive PDF Form that provides assistance to the applicants in preparing the CDRH medical device submission for 510(k)s and De Novos. The content of the form is automated with an automatic verification feature, and the structure is complementary to the internal review and also harmonized with the IMDRF and guided construction for each submission section.
The US FDA has announced a pilot program in collaboration with Health Canada. The practicability of using eSTAR will be determined by the outcome of 9 participants. The pilot program has eligibility criteria as below:
- Sponsorer must be in-process to submit an eSTAR application for the same medical device in Health Canada and US FDA within 6 months of acceptance into the pilot.
- The submission must be for a new or significant change amendment to Class III or IV submission of Health Canada OR
- A 510(k), De Novo or Pre-market Approval (PMA) original, 180-day, real-time or panel track supplement to FDA
- The Sponsorer must complete the eSTAR application
- The pilot program is NOT applicable to IVD devices, Combination products, CBER products or an FDA dual 510(k)/CLIA waiver application.
The limitations for the eSTAR pilot:
- Health Canada will not accept Regulatory Enrollment Process (REP) submission
- Submissions are accepted only in English at present.
Interested device sponsors can send in their participation request at [email protected] and [email protected] with the subject line “Request for participation in eSTAR Pilot”. The participation email should cover the following points:
- A statement asking to participate in the pilot
- Applicant name
- Contact name and title
- Device trade name(s) `
- The FDA primary product code, Global Medical Device Nomenclature (GMDN) and Preferred Name Code (PNC) of your device
- A statement that the same medical device using the eSTAR will be submitted within 6 months of acceptance in the eSTAR pilot to both Health Canada and the FDA:
- For Health Canada: specify if it is a new or significant change amendment for a Class III or IV submission
- For FDA: specify if it is a 510(k), De Novo or PMA submission (specify if the PMA submission is original, 180-day, real-time or a panel track supplement)
The FDA and Health Canada intend to revert to emails within 3 business days. The file size should be Less Than 1 GB, and images and videos to be submitted in compressed format. The fee structure is as follows:
Once accepted into eSTAR pilot, FDA & Health Canada will provide the Sponsor with the following items:
- eSTAR to prepare the submission
- Submission process information via the internet and mail service. Sponsorer can choose which route to adopt.