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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

Fenwick & West LLP

Key Changes in the Final and Proposed Digital Content and Cloud Computing Regulations

Fenwick & West LLP on

The U.S. Department of Treasury (Treasury) released final and proposed regulations under § 861 of the Code addressing the U.S. federal income tax classification of digital content and cloud computing transactions (the “Final...more

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