ACRP 2018 Meeting & Expo

346 - FDA Device Center Reorganization - What You Need to Know

Apr 30, 2018 3:00pm ‐ Apr 30, 2018 4:00pm


Credits: None available.

Members: $25.00
Standard: $75.00

Description

This session will provide an overview of the reorganization of the FDA's Center for Devices and Radiological Health (CDRH). Scheduled to begin mid-2018, this significant restructuring will combine the CDRH Office of Compliance, Office of Surveillance and Biometrics and the Office of Device Evaluation into a "super-office," designed to increase efficiency and effectiveness and to focus on the total product life cycle of medical devices. The restructuring will allow CDRH to review, clear or approve pre-market medical devices and assess these products and their legal manufacturers after market in one office. The FDA's goals for this move are to enhance information sharing throughout the center, address staffing challenges, improve engagement and professional development of employees, and update IT systems. Attendees will learn how this office will impact submissions, the reporting process, and inspections. The session will also examine the CDRH's three-year plan outlining its priorities, including employee engagement, streamlining of processes, and building collaborative communities.

Learning Objectives:

  • Understand how the restructuring of CDRH will impact future submissions
  • Define at least 2 changes to the reporting and inspection processes resulting from the restructuring
  • Describe how your organization will participate in building collaborative relationships with CDRH

Speaker(s):

  • Deborah Rosenfelder, BSN,CCRC,FACRP, Clinical Data Scientist, Becton Dickinson
  • Christopher Cain, CCRA, RAC, VP, Clinical and Regulatory Affairs, Corindus Vascular Robotics, Inc.

Credits Available


FDA Device Center Reorganization - What You Need to Know

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Janet Holwell
8/10/18 12:57 am

Slides are not provided. Only 3 slides are in the download file. Please upload the full set of slides. Thank you.