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
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• A Case Study on Medical Device Determination and Product Classification – Kim Piermatteo
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• 510(k) Program Updates – Angela Demarco
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• Appropriate Use of Voluntary Consensus Standards and the Conformity Assessment Program – Scott Colburn
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• Facilitating Patient Access to Medical Devices: The Expanded Access, Early Feasibility Study, and Breakthrough Devices Programs – Maureen Dreher
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• Building Quality Clinical Data into Premarket Approval Applications (PMAs) – Donna Headlee
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Day Two:

• Quality System Regulation and ISO 13485 Comparison: Corrective and Preventive Action (CAPA) Requirements – Joseph Tartal
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• Corrective and Preventive Action (CAPA) Case Study – Tonya Wilbon
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• Quality System: FDARA, 21st Century Cures Act, and Recent Postmarket Policy Updates – Vidya Gopal
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• Medical Device Single Audit Program (MDSAP) Overview – Kenneth Chen
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• FDA’s Import Requirements for Medical Devices – Terri Garvin
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• Overview of the FDA Exports Program for Medical Devices – Ethny Obas
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• FDA Medical Device Inspections – Maura Rooney
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