On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
FDA revised guidance documents for low-risk wellness products and clinical decision software, clarifying regulatory ...
The guidance, posted online on November 4, intended to provide information regarding the recommended documentation to include in premarket submissions for the FDA to evaluate the safety and ...
On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance ...
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