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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

Skadden, Arps, Slate, Meagher & Flom LLP

"Expansion of Military End-Use Controls Creates Potential Pitfalls for Exporters"

Skadden, Arps, Slate, Meagher & Flom LLP on

On November 7, 2014, the U.S. Commerce Department’s Bureau of Industry and Security (BIS) announced a final rule implementing controls on exports, re-exports and transfers of a variety of goods, software and technologies for...more

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