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Software Machine Learning Food and Drug Administration (FDA)

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

Hogan Lovells

FDA permits pre-approval for changes to AI devices via Predetermined Change Control Plans

Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) finalized guidance on the types of information that should be included in a Predetermined Change Control Plan (PCCP) as part of a marketing submission for an artificial...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

Sheppard Mullin Richter & Hampton LLP

FDA Releases Long-Anticipated Guidance on Predetermined Change Control Plans for Devices That Utilize AI/ML Software

FDA’s primary challenge in regulating AI-enabled device software functions (“AI-DSF”) has been that the self-modifying nature of these functions simply does not fit within the Agency’s long-standing framework for medical...more

Epstein Becker & Green

Unpacking Averages: CDRH Recognition of Consensus Standards Appears to Overlook Software

Epstein Becker & Green on

For decades, FDA’s Center for Devices and Radiological Health (CDRH) has been recognizing standards that can be referenced in premarket medical device submissions....more

Cooley LLP

Artificial Intelligence/Machine Learning Medical Device Regulatory Handbook

Cooley LLP on

Even before the Biden administration issued a landmark executive order on October 30, 2023, establishing new standards for artificial intelligence (AI) safety and security, the US Food and Drug Administration (FDA) had been...more

King & Spalding

Predetermined Change Control Plans (PCCPs) for Medical Devices: FDA Issues Draft Guidance

King & Spalding on

On August 22, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled, Predetermined Change Control Plans for Medical Devices. The draft guidance describes how FDA plans to implement new...more

Mintz - Health Care Viewpoints

FDA Needs a New Approach to AI/ML-Enabled Medical Devices

We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital technology, such as launching the...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

Epstein Becker & Green

FDA Oversight of AI Software Developed by Health Care Providers

Epstein Becker & Green on

Introduction - Hardly a day goes by when we don’t see some media report of health care providers experimenting with machine learning, and more recently with generative AI, in the context of patient care. The allure is...more

King & Spalding

FDA Finalizes Its Premarket Submissions Guidance for Medical Device Software Functions

King & Spalding on

On June 14, 2023, FDA finalized its “Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff” (the “2023 Final Guidance”). The Final Guidance replaces the...more

Goodwin

FDA Issues Draft Guidance for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions

Goodwin on

The US Food and Drug Administration (FDA or the Agency) recently issued its draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...more

MoFo Life Sciences

FDA Publishes Draft Guidance For Predetermined Change Control Plan For AI/ML-Enabled Device Software Functions

MoFo Life Sciences on

On April 3, 2023, FDA released the draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions”...more

Knobbe Martens

AI & the FDA

Knobbe Martens on

The use of artificial intelligence (AI) in healthcare has been growing rapidly in recent years, and AI-enabled medical devices are playing a larger role in patient care. Such devices may use machine learning algorithms to...more

Womble Bond Dickinson

Artificial Intelligence - The Promise of Early Disease Diagnosis and Improved Treatment and the Potential of Liability

Womble Bond Dickinson on

If there is one thing that everyone can agree on, it is that health is an important factor in life. In 2021, over 3 million people died in the United States with heart disease and cancer topping the list....more

Gardner Law

The Evolving FDA Regulatory Landscape of Artificial Intelligence

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As artificial intelligence technology evolves on a seemingly minute-by-minute basis, the U.S. FDA’s regulatory approach continues to evolve in an effort to keep pace. “The promise of artificial intelligence in medicine is...more

Mintz - Health Care Viewpoints

California Attorney General Probes Bias in Health Care Algorithms

A spurt of letters from California Attorney General Rob Bonta to leaders of hospitals and other health care facilities sent on August 31, 2022 signaled the kickoff of a government probe into bias in health care algorithms...more

MoFo Tech

AI TRENDS FOR 2022 - FDA REGULATORY

MoFo Tech on

FDA is actively monitoring the use of AI and machine learning (ML) software in medical devices and clinical developments, and has taken a number of first steps in building out a regulatory framework. In 2021, FDA published...more

Mintz - Health Care Viewpoints

Coverage of FDA’s AI/ML Medical Devices Workshop - Part 1: The History of FDA Software Regulation

In anticipation of FDA’s virtual public workshop on transparency of artificial intelligence/machine learning (AI/ML)-enabled medical devices scheduled for October 14, 2021, we will be posting a series detailing the history...more

Butler Snow LLP

Looking Beyond the Pandemic – AI and Digital Health Kick into Warp Speed

Butler Snow LLP on

What This Means for the FDA and the Industry - The COVID-19 pandemic has spurred the development of digital health products utilizing artificial intelligence (AI) and machine learning (ML). When the pandemic passes, there...more

Morgan Lewis

Three Considerations for AI Healthcare Application Developers and Users

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The applications of artificial intelligence (AI) are seemingly innumerable with benefits reportedly as prolific as the technology behind them, including in the healthcare space. To keep pace, the US Food and Drug...more

Morgan Lewis

FDA Issues Proposal on Oversight of Artificial Intelligence and Machine Learning Software

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The Food and Drug Administration’s recent discussion paper suggests a new regulatory approach for evaluating postmarket changes to artificial intelligence and machine learning software devices, but further clarity is needed...more

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