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Software Final Guidance Medical Devices

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FDA Issues Final Guidance on Predetermined Change Control Plans for AI-Enabled Devices

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On December 3, 2024, the US Food and Drug Administration (FDA) published final guidance titled, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software...more

King & Spalding

FDA Publishes Final Predetermined Change Control Plan Guidance for AI-Enabled Device Software Functions

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On December 4, 2024, FDA finalized its guidance entitled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions” (the “2024 Final...more

Ropes & Gray LLP

FDA Finalizes Guidance on Predetermined Change Control Plans for AI-Enabled Medical Device Software

Ropes & Gray LLP on

On December 4, 2024, the U.S. Food and Drug Administration (“FDA”) released its final guidance for industry on predetermined change control plans (“PCCPs”) for devices that utilize artificial intelligence-enabled software...more

King & Spalding

FDA Finalizes Premarket Cybersecurity Guidance for Medical Devices

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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

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

McDermott Will & Emery

FDA Issues Long-Awaited Final Clinical Decision Support Software Guidance

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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(FDA) issued its final Clinical Decision Support Software Guidance three years after the issuance of its 2019 revised draft guidance.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

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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

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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

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