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Final Rules › Software › Food and Drug Administration (FDA)

Gardner Law

FDA Finalizes Cybersecurity Premarket Guidance: What It Means for Medical Device Makers

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The FDA has finalized its guidance on cybersecurity for medical device premarket submissions, providing additional insight into the agency’s expectations for how manufacturers integrate cybersecurity risk management into...more

ArentFox Schiff

Devil Is Always in the Details: FDA Updates Device Classification Regulations To Remove Certain Software Functions

ArentFox Schiff on

On April 19, 2021, FDA issued a final rule that amends its device classification regulations to exclude from regulation as a medical device certain types of software functions for certain products. This final rule takes...more

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