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Artificial Intelligence › Draft Guidance › Public Comment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FDA Issues Draft Guidance Documents on Artificial Intelligence for Medical Devices, Drugs, and Biological Products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FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory decision about a drug or biological product’s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FDA Publishes Groundbreaking AI/ML Medical Device Draft Guidance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The U.S. Food and Drug Administration (“FDA”) has announced its first-ever draft guidance specifically addressing the use of artificial intelligence/machine learning (“AI/ML”) in medical devices (“Draft Guidance”).This...more

Proskauer - New Media & Technology

White House Releases Proposed Guidance for the Regulation of AI

Proskauer - New Media & Technology on

On January 7, 2019, the federal Office of Management and Budget (OMB) released a draft of a memorandum setting forth guidance to assist federal agencies in developing regulatory and non-regulatory approaches regarding...more

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