Media Coverage

Medhealth Review: Five Tips to the FDA eSTAR Application Submission Process

March 27, 2023

FDA eSTAR Submission Tips

The March 27, 2023 edition of Medhealth Review features Five Tips to the FDA eSTAR Application Submission Process by Alexandra (Sandy) Reid, QA/RA Specialist at StarFish Medical. Starting October 1, 2023, all 510(k) submissions, unless exempted, must be submitted electronically using eSTAR. Reid offers five tips to keep in mind when using the application for the first time.

Her recommendations range from the use of the correct eSTAR templates and reading the eSTAR 510(k) guidance to registration for the CDRH Portal and how to store your attachment with the submission. “The eSTAR program is the FDA’s current approach to implementing the electronic submission requirements in the amended FD&C Act. If the FDA continues to follow the list in the master guidance, a template for PMAs would be next.”

Reid concludes: “The currently available templates provide an easy way for applicants to understand and plan for the regulatory requirements for their 510(k) or De Novo medical device submissions.”

Alexandra (Sandy) Reid is a QA/RA Specialist at StarFish Medical. She provides support to StarFish clients in the form of documentation generation, review and general quality and regulatory guidance for medical devices. She has a PhD in plant molecular biology, has filed several patents on manufacturing therapeutic proteins in plants, and was a reviewer for Canadian Federal natural sciences and engineering grant applications before joining StarFish.

« All Media Coverage

Join over 6000 medical device professionals who receive our engineering, regulatory and commercialization insights and tips every month.