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Medical Devices › Algorithms › Software

Hogan Lovells

AI Health Law & Policy: Complying with FDA GMP rules for AI-enabled diagnostic devices

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter citing a failure to obtain marketing authorization via a premarket approval (PMA) or 510(k) clearance as well as Good Manufacturing Practice (GMP)...more

Mintz - Health Care Viewpoints

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

Mintz - Health Care Viewpoints on

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

Foley & Lardner LLP

Software as a Medical Device: Challenges Facing the Industry

Foley & Lardner LLP on

Editor’s Note: We are excited to announce that this article is the first of a series addressing Software as a Medical Device and the issues that plague digital health companies, investors, clinicians and other organizations...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FDA Publishes Draft Guidance For Predetermined Change Control Plan For AI/ML-Enabled Device Software Functions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On April 3, 2023, FDA released the draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device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

Gardner Law

The Evolving FDA Regulatory Landscape of Artificial Intelligence

Gardner Law on

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

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

King & Spalding

FDA Proposes Regulatory Framework for Artificial Intelligence/Machine Learning Software as a Medical Device

King & Spalding on

On April 2, 2019, the U.S. Food and Drug Administration (“FDA” or “Agency”) proposed a new regulatory framework to address the development and marketing of artificial intelligence and machine learning-based software as a...more

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