Wednesday, May 29
10:20 – 10:30 Day One Introductions – A brief overview of day one. Elias Mallis
10:30 – 11:10 Keynote: Incorporating a Total Product Life Cycle Approach
11:10 – 11:50 A Case Study on Medical Device Determination and Product Classification
11:50 – 1:05 p.m. NETWORKING LUNCH
1:05 – 1:45 510(k) Program Updates
1:45 – 2:25 Appropriate Use of Voluntary Consensus Standards and the Conformity Assessment Program
2:25 – 2:45 NETWORKING BREAK
2:45 – 3:25 Facilitating Patient Access to Medical Devices: The Expanded Access, Early Feasibility Study, and Breakthrough Devices Programs
3:25 – 4:05 Building Quality Clinical Data into Premarket Approval Applications (PMAs)
4:05 – 4:30 Q&A Sessions with the Day One Speakers
5:00 – 7:00 p.m. NETWORKING OPPORTUNITY
Thursday, May 30
8:35 – 8:50: Administrative Announcements – Day Two Introductions
9:00 – 9:40 Quality System Regulation and ISO 13485 Comparison: Corrective and Preventive Action (CAPA) Requirements
9:40 – 10:20 Corrective and Preventive Action (CAPA) Case Study
10:20 – 10:40 NETWORKING BREAK
10:40 – 11:20 Quality System: FDARA, 21st Century Cures Act, and Recent Postmarket Policy Updates
11:20 – 12:00 Medical Device Single Audit Program (MDSAP) Overview
12:00 – 1:15 p.m. NETWORKING LUNCH
1:15 – 1:55 FDA’s Import Requirements for Medical Devices
1:55 – 2:35 Overview of the FDA Exports Program for Medical Devices
2:35 – 2:55 BREAK
2:55 – 3:35 FDA Medical Device Inspections
3:35 – 3:40 Closing Remarks
3:40 – 4:20 Q&A Sessions with the Day Two Speakers