Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions
FDA Law Blog
MAY 8, 2023
Once FDA has cleared or approved a PCCP, that statute states that a supplemental application “shall not be required” to make a change consistent with such PCCP. Manufacturers should be able to verify and validate the proposed modifications within their existing quality system.
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