The Food and Drug Safety Administration recognizes ‘evidence of actual use’ as clinical data for digital manipulation devices
The Ministry of Food and Drug Safety (Minister Oh Yoo-gyeong) has approved clinical trial data for medical devices applied with digital technologies such as big data and artificial intelligence (AI), etc. On the 1st, it was announced that the ‘Regulations on Medical Device Approval, Notification, Review, etc’ were amended. RWE relates to the results of […]