(Cheongju = Sejong Chungcheong News) Reporter Seongha Kim = The Ministry of Food and Drug Safety has established evaluation criteria such as safety and performance for the rapid commercialization of three artificial intelligence (AI) medical device software that are being developed as diagnostic aids for dementia, prostate cancer, and colon cancer. It was developed and produced as a guide.
The main contents of this guide are the safety and performance evaluation criteria of artificial intelligence (AI) software, medical device cyber security application method, clinical trial design method, and efficacy evaluation criteria.
In addition, the developed evaluation criteria were technicalized by forming a consultative body with the developer so that the optimum criteria for safety and performance evaluation can be followed from the development stage of the product.
It was also promoted to support the development of the Ministry of Science, ICT, and ICT’s’Doctor Answers’ program, an artificial intelligence (AI) service that supports doctors’ medical treatment and diagnosis through medical big data as part of the’Korean version of the New Deal Comprehensive Plan’.
The Ministry of Food and Drug Safety expects that, according to the development of this evaluation standard, future developers will be able to increase efficiency in procedures such as product development strategy preparation, clinical trial planning, and approval.
In addition, it was selected as the first chairman of this year’s International Medical Device Regulatory Forum (IMDRF) Artificial Intelligence Medical Device Working Group, and led the international standard of artificial intelligence medical device technology by preparing the world’s first’Artificial Intelligence Medical Device Guideline’ in 2017. Are doing.
In addition, the Ministry of Food and Drug Safety has produced a video that introduces the targets and main contents of 10 types of artificial intelligence medical device guidelines published so far.
The Ministry of Food and Drug Safety plans to preemptively provide evaluation criteria for advanced medical devices and actively support the product development of the’Doctor Answers’ program so that patient treatment opportunities can be expanded through research and development of advanced medical devices.
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