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Gardner Law

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

Gardner Law on

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

BakerHostetler

DSIR Deeper Dive: Artificial Intelligence - Banner Years (and Counting) for AI Guidance and Regulation

BakerHostetler on

The period of 2024-2025 was significant for AI law, regulation, and guidance, beginning in early February 2024, and the news told the tale...more

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