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Risk Management › New Guidance › Software

Hogan Lovells

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

Hogan Lovells on

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

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

Sheppard Mullin Richter & Hampton LLP

FedRAMP 20x – Update on Significant Change Process and Assessment Scope Standards

Sheppard Mullin Richter & Hampton LLP on

Last month, the federal government announced a major overhaul of the Federal Risk and Authorization Management Program (“FedRAMP”) called “FedRAMP 20x”. FedRAMP 20x is moving forward fast – with new authorizations, community...more

Spilman Thomas & Battle, PLLC

Promissory Notes - Banking & Finance Insights: V 4, Issue 1, January 2024

Spilman Thomas & Battle, PLLC on

OCC Issues Guidance on ‘Buy Now, Pay Later’ Lending - “The guidance notes that banks should maintain underwriting, repayment terms, pricing, and safeguards that minimize adverse customer outcomes and should ensure that...more

Robinson+Cole Data Privacy + Security Insider

NIST Releases Guidance on Supply Chain Security

Robinson+Cole Data Privacy + Security Insider on

The National Institutes of Science and Technology (NIST) Information Technology Laboratory recently released guidance entitled “Software Supply Chain Security Guidance,” in response to directives set forth in President...more

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