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# eSTAR e-Submissions Open for PMAs
- URL: https://www.fdaweb.com/estar-e-submissions-open-for-pmas/
- Published: 2023-12-06T12:00:00.000Z
- Updated: 2026-09-14T14:17:54.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155932

FDA has opened its eSTAR electronic submission template for voluntary use for certain PMA submissions. The agency says the eSTAR interactive PDF form is intended to guide applicants through preparing a comprehensive medical device submission. “eSTAR is intended to enhance the incoming quality of submissions for a wide range of medical devices by helping to ensure submitters provide quality, comprehensive data for premarket review,” an [agency notice](https://www.fda.gov/medical-devices/how-study-and-market-your-device/estar-program?utm%5Fmedium=email&utm%5Fsource=govdelivery) says. eSTAR’s expansion now allows original PMAs, PMA panel track supplements, PMA real-time supplements, and PMA 180-day supplements.

Previously, all 510(k) submissions, unless exempted, were required to be submitted as electronic submissions using eSTAR, as noted in the final guidance: [Electronic Submission Template for Medical Device 510(k) Submissions](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-submission-template-medical-device-510k-submissions?ref=fdaweb.com).

FDA also notes that the updated eSTAR Template includes a guide that follows the recommendations noted in the final guidance: *Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions*. “The recommendations are intended to promote consistency, facilitate efficient premarket review, and help ensure that marketed medical devices are sufficiently resilient to cybersecurity threats,” the agency says.