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New Regulations Software New Guidance

Hogan Lovells

FDA finalizes cyber device “select updates” guidance, potentially affecting substantial equivalence findings for 510(k)s

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The U.S. Food and Drug Administration (FDA) recently finalized its March 2024 select updates to its guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (“Premarket...more

Foley Hoag LLP - White Collar Law &...

White Collar Year in Preview: Sanctions/Export Controls Trends in 2020

This is the sixth in our start-of-year series examining important trends in white collar law and investigations in the coming year. Our previous entry discussed enforcement by the Massachusetts Attorney General’s Office in...more

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