2019 MDMA FDA Forum Agenda


                    

*Speakers will be added as confirmed

Click Here for a PDF of the Agenda

*Attendees receive up to 6 credits towards RAC re-certification upon completion

Thursday, March 14, 2019

7:30am - 8:25am

Registration & Continental Breakfast

8:25am - 8:30am

Welcome, Opening Remarks

  • Mark Leahey, President & CEO, MDMA

8:30am - 9:15am

Navigating the 510(k) Program

  • Heather Rosecrans, Vice President, Regulatory Affairs, MDMA
  • Marjorie Shulman, Director, Premarket Notification 510(k) and 513(g) Programs, Program Operations Staff, Office of Device Evaluation, CDRH, FDA

9:15am - 10:00am

Do's & Don't's of Pre-Submission Meetings

  • Joshua Nipper, Director, PMA, HDE, & Q-Sub Programs, Program Operations Staff, Office of Device Evaluation, CDRH, FDA

10:00am - 10:20am

Networking Break

10:20am - 11:05am

De Novo Program

  • Sergio M. de del Castillo, De Novo Program Lead, Office of Device Evaluation, CDRH, FDA

11:05am - 11:50am

PMA Review Considerations

  • Joshua Nipper, Director, PMA, HDE & Q-Sub Programs, Program Operations Staff, Office of Device Evaluation, CDRH, FDA

11:50am - 12:30pm

Strategies to Succeed During the Review Process

  • William Maisel, MD, MPH, Director, Office of Compliance (Acting), Director, Office of Device Evaluation (Acting), Chief Scientist, CDRH, FDA

12:30pm - 1:30pm

Networking Lunch

1:30pm - 2:15pm

Combination Products

2:15pm - 3:00pm

Digital Health

  • Bakul Patel, MSEE, MBA, Associate Center Director for Digital Health, Office of the Center Director, CDRH, FDA

3:00pm -  3:15pm

Networking Break

3:15pm - 4:00pm

Key Issues Impacting IVD's

  • Timothy Stenzel, MD, PhD, Director, Office of In Vitro Diagnostics and Radiological Health, CDRH, FDA

4:00pm - 4:45pm

Inspections

4:45pm -5:05pm

MDUFA Independent Assessment

  • Matt Healy, Principal, Booz Allen Hamilton

5:05pm - 6:00pm

Networking Reception

 

Friday, March 15, 2019

7:30am - 8:00am

Registration and Continental Breakfast

8:00am - 8:45am

CDRH Update

  • William Maisel, MD, MPH, Director, Office of Compliance (Acting), Director, Office of Device Evaluation (Acting), Chief Scientist, CDRH, FDA

8:45am - 9:30am

Industry Reaction

9:30am - 10:15am

Future of 510(k)?

  • William Maisel, MD, MPH, Director, Office of Compliance (Acting), Director, Office of Device Evaluation (Acting), Chief Scientist, CDRH, FDA

10:15am - 10:30am

Networking Break

10:30am - 10:50am

MDUFA - Supported Patient Program

  • Kathryn M. O'Callaghan, Assistant Director for Strategic Programs, Office of the Center Director, CDRH, FDA
  • Michelle Tarver, Director, Patient Science & Engagement Program, Office of the Center Director, CDRH, FDA

10:50am - 11:10am

Demonstration of eSTAR Platform

  • Patrick Axtell, Senior Tools & Templates Engineer, Office of Device Evaluation, CDRH, FDA

11:10am - 12:00pm

CyberSecurity & Hot Topics

12:00pm - 1:00pm

ADJOURN - BOX LUNCH


         

Sessions and speakers are subject to change without notice. MDMA reserves the right to cancel or reschedule any program, whereupon full registration fees will be refunded or applied to the rescheduled program in accordance with the registrant's preference. In the event of canceled programs, MDMA assumes no responsibility for transportation, hotel, or other expenses incurred by registrants.