Category: FDA Compliance

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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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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Medical Device Cybersecurity

Medical Device Accessory or Component and the FDA – The Fine Line Between Them

Determining if your medical product or innovation should be considered a component or an accessory is a critical early-life cycle inflection point. In fact, the distinction between the two terms has long been the subject of debate and interpretation. In August 2017, the FDA began a new effort to classify a “list of [medical device]...
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FDA Recognized Consensus Standards

FDA Announces New Policy for Accepting Consensus Standards for Medical Devices

FDA Streamlines Process for Accepting Consensus Standards We are seeing the impact of the 21st Century Cures Act yet again with FDA’s clarification on how they will process requests for recognition of consensus standards. With this new policy, FDA has streamlined the process that allows medical device manufacturers to submit a request to the FDA...
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