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國內外智慧醫材法規文件
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Clinical Decision Support Software, 2022
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(FDA)Proposed Regulatory Framework for Modifications to Artificial Intelligence Machine Learning-Based Software as a Medical Device (SaMD), 2021
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Software as a Medical Device (SAMD): Clinical Evaluation, 2017
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Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act - Guidance for Industry and Food and Drug Administration Staff, 2019.
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Clinical Decision Support Software - Draft Guidance for Industry and Food and Drug Administration Staff, 2019
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Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff, 2019.
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General Wellness: Policy for Low Risk Devices - Guidance for Industry and Food and Drug Administration Staff, 2019.
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Policy for Device Software Functions and Mobile Medical Applications, 2019.
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Deciding When To Submit A 510(k) for a Change to an Existing Device - Guidance for Industry and Food and Drug Administration Staff, 2017
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Computer Software Assurance for Production and Quality System Software, 2022
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