US FAD has developed an action plan to regulate SaMD using AI and machine learning
 
The U.S. FDA recently released an initiative for Smart and Machine Learning (AI/ML) Software as a Medical Devices (SaMD) to promote the supervision of AI/ML medical devices.
 
Bakul Patel, Digital Health Center of Excellence (DCE) of CDRH, stated, “This initiative shows that the FDA will further strengthen the control of AI/ML medical software equipment. The content of the plan is mainly based on the entire product life cycle. The regulatory approach of these technologies enhances the huge potential of these technologies in improving medical care, while providing safe and effective software functions to improve the quality of care received by patients.”
 
Bakul Patel also stated that in order to keep up with the times to solve patient safety issues and improve access to these technologies, the plan will be improved over time.
 
The DCE was established in September 2020 and is dedicated to the science and evidence for advancing digital health technologies within the supervision and supervision of the FDA. The goal of the center is to enable stakeholders to improve healthcare by promoting reliable and high-quality digital medical innovation. Based on the AI/ML Software as a Medical Device (SaMD) action plan, the FDA announced five actions it will take in the near future:
 
1. Further develop a tailored regulatory framework, including the issuance of a draft guideline for the scheduled change control plan (for the periodical learning of the software)
 
2. Support the development of a good machine learning process (GMLP) for evaluation and improvement Machine learning algorithms

3. Focus on patients and improve the transparency of the device to users

4. Develop methods for evaluating and improving machine learning algorithms

5. Develop real-world data
 
As far as we know that that the AI/ML software as a medical device (SaMD) action plan is based on a discussion document released by the FDA in 2019. At that time, it responded to numerous feedbacks from stakeholders, including hundreds of public opinions, and then proposed a protocol framework for regulating AI and SaMD. With the release of the first action plan, the FDA pointed out that it welcomes continued feedback from all walks of life and looks forward to engaging with stakeholders.

refrence:https://ibmi.taiwan-healthcare.org/news_detail.php?REFDOCTYPID=&REFDOCID=0qn5qeofnzc060yw
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