Blog

eSTAR Submissions, a new method for US FDA Medical Device Submissions – Identifying and Overcoming eSTAR Challenges for a Successful Submission

As of October 1, 2023, all 510(k) submissions must be submitted as electronic submissions using eSTAR through the CDRH Portal for CDRH or the Electronic Submission Gateway (ESG) for CBER. eSTAR is an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission. FDA created eSTAR with the following...
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Please join MethodSense, Arrow & Infineon on October 26th as we address critical FDA cybersecurity & compliance

Please be our guest Thursday, October 26th, in Bloomington, Minnesota for a discussion of the FDA’s latest Cybersecurity guidance! Rita King from MethodSense, a FDA regulatory and quality assurance compliance consulting firm, will offer her experience guiding customers through the FDA’s new Cybersecurity guidance. Patrick Carrier from Infineon, a supplier of embedded security components, will...
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Cybersecurity in Medical Devices: Impact of FDA’s New Cybersecurity Requirements

Note: This is the first in a ten-part series related to Cybersecurity and AI regulatory expectations in the medical product market.   The rapid advancement of technology has revolutionized the healthcare industry, bringing forth innovative medical devices that have improved patient outcomes and overall healthcare delivery. However, with the proliferation and integration of software driven,...
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