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:
Session 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