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Medical Devices › Artificial Intelligence › Public Comment

Sterne, Kessler, Goldstein & Fox P.L.L.C.

FDA Issues Draft Guidance Documents on Artificial Intelligence for Medical Devices, Drugs, and Biological Products

Sterne, Kessler, Goldstein & Fox P.L.L.C. on

FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory decision about a drug or biological product’s safety, effectiveness, or...more

Nelson Mullins Riley & Scarborough LLP

FDA Publishes Groundbreaking AI/ML Medical Device Draft Guidance

Nelson Mullins Riley & Scarborough LLP on

The U.S. Food and Drug Administration (“FDA”) has announced its first-ever draft guidance specifically addressing the use of artificial intelligence/machine learning (“AI/ML”) in medical devices (“Draft Guidance”).This...more

Goodwin

FDA Issues Guiding Principles for Good Machine Learning Practice for Medical Device Development

Goodwin on

On October 27, 2021, the U.S. Food and Drug Administration (FDA), Health Canada and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a set of ten guiding principles meant to aid the...more

McDermott Will & Emery

FDA Issues Good Machine Learning Practice Guiding Principles

McDermott Will & Emery on

On October 27, 2021, pursuant to the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan (Action Plan), the US Food and Drug Administration (FDA) released its Good Machine Learning...more

McDermott Will & Emery

Reviewing Key Principles from FDA's Artificial Intelligence White Paper

McDermott Will & Emery on

In April 2019, the US Food and Drug Administration (FDA) issued a white paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device,”...more

Sheppard Mullin Richter & Hampton LLP

Medical Devices - Artificial Intelligence and Reactions to FDA’s Proposed Oversight

Sheppard Mullin Richter & Hampton LLP on

In April of this year, the US Food and Drug Administration (FDA) released a discussion paper, Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML) – Based Software as a Medical...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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