On May 29-30, two offices in the US Food and Drug Administration – the Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA) and the Center for Devices and Radiological Health (CDRH) Division of Industry and Consumer Education (DICE)-- collaborated to hold an interactive workshop with the FDA’s regulatory experts. The course, titled Regulatory Education for Industry (REdI), provided participants with a basic foundation for understanding the FDA’s drug and medical device regulatory requirements. The following recordings from the devices track are now available:
REdIlogo 300Session Recordings: CDRH (Devices) Track
Day One:
  • Keynote: Incorporating a Total Product Life Cycle Approach – William Maisel
    View Recording
  • A Case Study on Medical Device Determination and Product Classification – Kim Piermatteo
    View Recording
  • 510(k) Program Updates – Angela Demarco
    View Recording
  • Appropriate Use of Voluntary Consensus Standards and the Conformity Assessment Program – Scott Colburn
    View Recording
  • Facilitating Patient Access to Medical Devices: The Expanded Access, Early Feasibility Study, and Breakthrough Devices Programs – Maureen Dreher
    View Recording
  • Building Quality Clinical Data into Premarket Approval Applications (PMAs) – Donna Headlee
    View Recording
Day Two:
  • Quality System Regulation and ISO 13485 Comparison: Corrective and Preventive Action (CAPA) Requirements – Joseph Tartal
    View Recording
  • Corrective and Preventive Action (CAPA) Case Study – Tonya Wilbon
    View Recording
  • Quality System: FDARA, 21st Century Cures Act, and Recent Postmarket Policy Updates – Vidya Gopal
    View Recording
  • Medical Device Single Audit Program (MDSAP) Overview – Kenneth Chen
    View Recording
  • FDA’s Import Requirements for Medical Devices – Terri Garvin
    View Recording
  • Overview of the FDA Exports Program for Medical Devices – Ethny Obas
    View Recording
  • FDA Medical Device Inspections – Maura Rooney
    View Recording

The Focused Ultrasound Foundation Newsletter

Our newsletter delivers updates for clinicians, researchers and patients. Sign up and stay on top of the rapid advancements of this innovative medical technology.

Sign Up  Read the Latest Issue

Read The Tumor  by John Grisham

From John Grisham, comes a story where today’s medical fiction could become tomorrow’s lifesaving reality.

Download a Free eBook or Audiobook

Contact Details

Call Us
434.220.4993
Find Us
Focused Ultrasound Foundation
1230 Cedars Court, Suite 206 Charlottesville, VA 22903
Email