Please join the Indiana Medical Device Manufacturers Council (IMDMC) for our
Analysis of Recent 510(k) Submission Guidances Workshopon February 22, 2012 Agenda
| 9:30-10:30 EST | Welcome / New 510(k) paradigm | Ralph Hall, Faegre Baker Daniels |
| 10:30-11:00 | Use of Experts | Daniel J. Dillon, MS, RAC (US) MED Institute |
| 11:00-11:15 | Break | |
| 11:15-12:15 | 5 Hot Topics! NTI Center Science Council RUO Chemical action/definitions de novo |
Ralph Hall, Faegre Baker Daniels Gretchen Bowker, Pearl IRB Scott Thiel, The Anson Group Brandon Hipsher, DePuy Orthopaedics Daniel J. Dillon, MED Institute |
| 12:15-1:00 | Lunch provided | |
| 1:00-2:15 | Modifications | Scott Thiel, The Anson Group |
| 2:15-2:45 | New HDE Guidance | Jack Rogers, Beckman Coulter (invited) |
| 2:45-3:15 | Appeals | Brandon Hipsher, DePuy Orthopaedics |
| 3:15 pm | Adjourn |
Registration Fees: $125 IMDMC Member / $175 Non-Member
Location: Montage, 8580 Allison Pointe Blvd, Indianapolis, IN 46250
Please register to attend the event now!
