Lexology April 12, 2023
On March 30, the U.S. Food and Drug Administration (FDA) published draft guidance that proposes recommendations on the types of information that should be included in a Predetermined Change Control Plan (PCCP) in a marketing submission for a machine learning (ML)-enabled device software function. In the draft guidance, FDA describes the process by which ML device sponsors may seek approval for modifications in advance by submitting a PCCP document, which would describe the anticipated changes and how they will be tested and implemented. FDA is seeking comments on the draft guidance through July 3, 2023.
Background
A machine learning-enabled device software function (ML-DSF) uses a type of artificial intelligence called machine learning to analyze data and make predictions or decisions...
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