[2020 US FDA Regulatory Education for Industry (REdI) Annual Conference]

 一年一度的US FDA REdI Annual Conference就在前幾天落幕了， REdI Annual Conference其目的是提供參與者了解目前FDA關於藥品以及醫材的最新法規資訊,因此CDER(Drugs)與CDRH(Devices)各自會帶來多場的精彩演講，以今年CDRH的演講為例，不難可以觀察到CDRH花了不少功夫來說明510(k)最近的更新與De Novo pathway．

雖然今年度的REdI Annual Conference已經結束了，但是貼心的US FDA已經迅速地將演講的slides以及recording全都公開上傳到網路上供大家觀看，這對於海外的廠商而言真是一大福音！大家可以透過底下連結來充電一下US FDA最新的法規新知吧！

REdI Annual Conference 2020

Agenda_CDRH (Devices) session:

• Benefit-Risk Throughout the Medical Device Lifecycle: Premarket, Postmarket, and Compliance – Kimberly Brown Smith
• 510k Device Modifications: Case Study – Melissa Hall
• A New Way to 510k: The Safety and Performance Based Pathway – Jason Ryans
• De Novo Classification: An Alternative Pathway to Market for New Device Types – Sergio de del Castillo
• Considering Cybersecurity in Device Development and Factors Influencing Successful Premarket Review – Lisa Simone
• Design Controls: Case Study – Joseph Tartal
• Production and Process Controls: Case Study – Vidya Gopal
• Case for Quality – Francisco Vicenty
• Medical Device Single Audit Program (MDSAP) – Kenneth Chen
• Risk Management Within A Quality System – Tonya Wilbon
• eMDR System Overview and Submission Walkthrough – Evan Jacobs
• FDA Medical Device Inspections – Laureen Genuisz

備註: 這邊小抱怨一下,為什麼CDER (Drugs) session recordings都有自己的youtube channel,但CDRH (Devices)還是要安裝adobe webinar system才能看 TAT