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Sheppard Mullin Richter & Hampton LLP

FedRAMP Releases New Draft Authorization Boundary Guidance

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Over the last few years, the Federal Risk and Authorization Management Program (“FedRAMP”) Program Management Office (“PMO”) has released two draft guidance documents related to defining the applicable boundary for security...more

Hogan Lovells

New FDA electronic records guidance prioritizes Digital Health Technology oversight

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On March 15, the U.S. Food and Drug Administration (FDA) issued revised draft guidance summarizing how it intends regulate the use of electronic systems, records, and signatures in clinical investigations to account for...more

Hogan Lovells

“Remanufacturing” or “Servicing”? New FDA guidance clarifies distinction for medical devices

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On June 18, 2021, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Remanufacturing of Medical Devices,” which aims to help clarify the point when manipulation or repair of a medical device becomes...more

Sheppard Mullin Richter & Hampton LLP

NIST Seeking Comments on Draft AI Principles

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The National Institute of Standards and Technology has issue a set of draft principles for “explainable” artificial intelligence and is accepting comments until October 15, 2020. The authors of the draft principles outline...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues New Draft Cybersecurity Guidance for Medical Devices

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The Food & Drug Administration has recently released for comment a draft expansion of guidance regarding Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Although the FDA issued existing...more

Jones Day

FDA Establishes Electronic Privacy, Security, and Reliability Criteria for Clinical Trial Records

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In March 1997, the Food and Drug Administration ("FDA") published a final rule, codified in 21 CFR Part 11 ("Part 11"), establishing the privacy, security, and reliability criteria for electronic records and electronic...more

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