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Have there been any recent changes to the FDA certification standards and requirements?
Category：行業(yè)資訊 Date：2024-11-07 17:18:27 Author: Source:
Yes, the FDA periodically updates its certification standards and requirements. Recent changes have focused on enhancing the efficiency of the approval process, improving transparency, and ensuring greater safety and effectiveness of medical devices. For instance, the FDA has been increasing its focus on digital health devices, cybersecurity considerations, and the use of real-world evidence (RWE) for approvals. The agency has also revised its guidance on 510(k) submissions and introduced new standards for software and AI-based medical devices.

Yes, the FDA periodically updates its certification standards and requirements. Recent changes have focused on enhancing the efficiency of the approval process, improving transparency, and ensuring greater safety and effectiveness of medical devices. For instance, the FDA has been increasing its focus on digital health devices, cybersecurity considerations, and the use of real-world evidence (RWE) for approvals. The agency has also revised its guidance on 510(k) submissions and introduced new standards for software and AI-based medical devices.7(2).jpg

To stay current, it's essential to monitor FDA updates regularly.

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