Agenda
Medical Devices 101 took place from 8:00 AM to about 5:00 PM on Friday, August 20, 2010, in San Antonio, Texas
| Registration and continental breakfast | |
| Introduction to FDA | David Arvelo, US Food and Drug Administration |
| Is It A Medical Device? | |
| Medical Device Classification | |
| Medical Device Establishment Registration | |
| Medical Device Listing | |
| Q&A session | |
| Break | |
| Premarket Notification [510(k)] | Dr. William Hyman, Texas A&M University |
| Q&A session | |
| Premarket Approval (PMA) | |
| Q&A session | |
| Investigational Device Exemptions (IDE) | |
| Humanitarian Device Exemptions (HDE) | |
| Q&A session | |
| Medical Device Labeling | |
| Q&A session | |
| Lunch (provided) | |
| Quality System Regulations (QSR) | Al Alonso, Regulatory Affairs Professionals Society |
| Q&A session | |
| Break | |
| Postmarket Surveillance | Al Alonso, Regulatory Affairs Professionals Society |
| Q&A session | |
| Recalls, Corrections, and Removals | David Arvelo, FDA |
| Medical Device Reporting and Tracking | |
| FDA Inspections | |
| Q&A session | |
| Special Cases | |
| Q&A session, evaluation, and wrap-up | |
