Posts tagged with “eSTAR”

Christian Fleischhacker

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

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 […]

Alexandra Reid

FDA and Health Canada streamline medical device submissions with joint eSTAR portal

The U.S. Food and Drug Administration (FDA) is partnering with Health Canada to launch a joint electronic Submission Template and Resource (eSTAR) pilot. The joint pilot, announced on January 10th, 2023, will test the feasibility of allowing sponsors to submit medical device submissions to both regulatory bodies through the FDA’s eSTAR online portal. Requests for […]

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