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Life Sciences › Draft Guidance › Artificial Intelligence

Faegre Drinker Biddle & Reath LLP

Race Against the Clock: Federal Agencies Issue Their Six-Month Updates on AI Activities in Accordance With President Biden’s...

Faegre Drinker Biddle & Reath LLP on

Since President Biden issued his sweeping Executive Order on the Safe, Secure and Trustworthy Development of AI on October 30 of last year (EO), federal agencies have been operating in high gear to meet the deadlines and...more

Hogan Lovells

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

Hogan Lovells on

On March 30, the U.S. Food and Drug Administration (FDA) published draft guidance that proposes recommendations on the types of information that should be included in a Predetermined Change Control Plan (PCCP) in a marketing...more

McDermott Will & Emery

FDA Issues Draft Predetermined Change Control Plan for Machine-Learning-Enabled Device Software Functions

McDermott Will & Emery on

On April 3, 2023, the US Food and Drug Administration (FDA) published its draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...more

Akin Gump Strauss Hauer & Feld LLP

Software and Digital Health Policies Issued by FDA

Akin Gump Strauss Hauer & Feld LLP on

Multiple policy documents relating to software and digital health have been issued by the U.S. Food and Drug Administration (FDA). The documents offer: a framework for the use of digital health tools in the context of drug...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FDA Publishes Groundbreaking AI/ML Medical Device Draft Guidance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The U.S. Food and Drug Administration (“FDA”) has announced its first-ever draft guidance specifically addressing the use of artificial intelligence/machine learning (“AI/ML”) in medical devices (“Draft Guidance”).This...more

Akin Gump Strauss Hauer & Feld LLP

FDA Changes Direction in Final CDS Guidance

Akin Gump Strauss Hauer & Feld LLP on

FDA Also Issues Report on Software Pre-Cert Pilot, Leaving Unanswered Questions on Future of Software Regulation - Key Points - The Final Guidance does not address the FDA’s risk-based enforcement discretion policy...more

Akin Gump Strauss Hauer & Feld LLP

FDA Releases Action Plan for Artificial Intelligence/Machine Learning-Enabled Software as a Medical Device

Akin Gump Strauss Hauer & Feld LLP on

Key Points - FDA will publish draft guidance on its Predetermined Change Control Plan in 2021 and host a public workshop on transparency requirements around AI/ML-based devices. - FDA plans to pilot Real-World Performance...more

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