![United States: FDA Issues Draft Guidance For Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions - Goodwin Procter LLP](https://cdn.newsserve.net/ONPglobe256.png)
United States: FDA Issues Draft Guidance For Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions - Goodwin Procter LLP
A PCCP must be reviewed by FDA and established as part of a marketing authorization prior to a manufacturer's implementing any modifications under the PCCP.
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