Category: FDA Compliance

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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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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