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Final Guidance Software

King & Spalding

FDA Finalizes Premarket Cybersecurity Guidance for Medical Devices

King & Spalding on

On September 27, 2023, FDA finalized its guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (the “2023 Final Guidance”). The Final Guidance replaces...more

Epstein Becker & Green

Podcast: Unpacking FDA's Final Clinical Decision Support Guidance - Diagnosing Health Care

The U.S. Food and Drug Administration (FDA) recently issued a final guidance document clarifying how the agency intends to regulate clinical decision support (CDS) software. How has this document caused confusion for...more

Skadden, Arps, Slate, Meagher & Flom LLP

Key Questions Remain Despite FDA Attempts To Clarify Guidance on Clinical Decision Software

Clinical decision support (CDS) software has been recognized — including by government agencies — as having significant potential to increase quality of care and enhance health outcomes, and companies across the health care...more

Goodwin

FDA Issues Final Clinical Decision Support Software Guidance

Goodwin on

​​​​​​​On September 28, 2022, the U.S. Food and Drug Administration (“FDA” or “the Agency”) issued its long-awaited final guidance, “Clinical Decision Support Software” (the “CDS Guidance”). The CDS Guidance follows the...more

King & Spalding

FDA’s Final Clinical Decision Support Guidance: The Good News and the (Really) Bad News

King & Spalding on

On September 28, 2022, the U.S. Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited final guidance, “Clinical Decision Support Software” (the “Final CDS Guidance”). The Final CDS Guidance supersedes...more

McDermott Will & Emery

FDA Issues Long-Awaited Final Clinical Decision Support Software Guidance

McDermott Will & Emery on

On September 28, 2022, the US Food and Drug Administration (FDA) issued its final Clinical Decision Support Software Guidance three years after the issuance of its 2019 revised draft guidance. The final guidance refines and...more

Foley & Lardner LLP

Developers Take Note: FDA Issues Clinical Decision Support Software Final Guidance

Foley & Lardner LLP on

On September 27, 2022, the Food and Drug Administration (FDA) issued its much anticipated final guidance for industry and FDA Staff, Clinical Decision Support Software. This guidance follows the draft Clinical Decision...more

McDermott Will & Emery

Is Your Software a Medical Device? FDA Issues Six Digital Health Guidance Documents

McDermott Will & Emery on

The FDA recently released six guidance documents as part of the agency’s continued focus on updating the regulatory stance on software as a medical device and other digital health products. The updated guidance documents...more

King & Spalding

NHTSA Releases Guidance on Enforcement of Safety-Related Defects in Automated Vehicle Technologies - Agency’s stance raises...

King & Spalding on

Last week, the National Highway Traffic Safety Administration (NHTSA) released its final Enforcement Guidance Bulletin on Safety-Related Defects and Automated Safety Technologies. The Guidance makes clear that the agency’s...more

Bennett Jones LLP

CRTC Provides Guidance on CASL Software Provisions – But Some Uncertainty Remains

Bennett Jones LLP on

From November 10 to 12, 2014, the CRTC provided its interpretation of the software provisions in Canada’s anti-spam law (CASL) in several presentations to industry. The CRTC also posted a specific FAQ about their...more

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