[FDA webinar series]: "Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics"

美國FDA於2018/09/24發布了一份準則 (Final Guidance)，這份準則的名稱為"Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics"，其內容具體規範當廠商申請510(k)途徑時，自家產品與比對品有著明顯的技術特徵差異，尤其是當自家產品相較於比對品提高風險或是降低效益的情況下，廠商如何藉由Benefit-Risk Analysis來協助FDA的法規審查！

底下為FDA/CDRH Webinar，一起來聽聽美國FDA如何闡述這份新的準則：

US FDA Webinar - Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics: Final Guidance - November 1, 2018