The Benefits and Considerations of FDA Pre-Submission Meetings Navigating the regulatory landscape for medical devices can be complex and challenging. One invaluable tool to streamline this process is the FDA’s Pre-Submission (Pre-Sub) program. This program offers medical device manufacturers an opportunity to engage in early and constructive dialogue with the FDA, potentially smoothing the path…
On January 6, 2025, the U.S. Food and Drug Administration (FDA) released a draft guidance aimed at developers of artificial intelligence (AI)-enabled medical devices. This document offers comprehensive recommendations to ensure the safety and effectiveness of AI-driven devices throughout their entire product lifecycle. The guidance emphasizes the importance of transparency and the mitigation of bias…
On Dec. 4, 2024, the U.S. Food and Drug Administration (FDA) issued a final guidance on “Marketing Submission Recommendations for a Predetermined Change Control Plan (PCCP) for Artificial Intelligence-Enabled Device Software Functions.” This guidance provides a framework for manufacturers to proactively plan for modifications to AI-enabled medical devices, ensuring that these updates maintain device safety…
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