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Fda Usa Issues Final Guidance Predetermined Change Control Plan Ai Enabled Device Software
18th December 2024 - Regulatory News
FDA (USA) Issues Final Guidance on Predetermined Change…
On December 4, 2024, the U.S. Food and Drug Administration (FDA) issued its final guidance, “Marketing Submission Recommendations for …
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United States Medical Devices
Ministry Food Drug Safety Revises Guidelines Expedited Review Innovative Medical Devices
10th September 2024 - Regulatory News
Ministry of Food and Drug Safety Revises Guidelines for…
The Ministry of Food and Drug Safety revised the “Innovative Medical Devices Priority Review Guidelines (Guide for Applicants)” …
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Medical Devices