lunes, 3 de noviembre de 2014

CDRH Industry: REMINDER: JOIN the Experts for live Q&A at the “CDRH Industry Basics Workshop” – Tuesday, November 4, 2014 (Live Webinar)

 Live Webinar
JOIN the Experts for live Q&A at the “CDRH Industry Basics Workshop”
November 4, 2014  10:00 a.m. to 4:00 p.m. EST

On November 4, 2014, CDRH’s Division of Industry and Consumer Education (DICE) will host the CDRH Industry Basics Workshop (see detailed agenda below).

Target Audience:
Medical device manufacturers and/or developers seeking the fundamental concepts of medical device regulations will find this workshop helpful.

The workshop will feature five sessions, each of which will consist of a presentation followed by a question and answer session with a panel of experts.   You will be able to email or call us with your questions during each session.

Schedule of Events (Eastern Standard Time)
You can choose to participate in any and/or all of the sessions.  Each session will begin precisely at the scheduled time. There is no fee to attend and registration is not required.

  •  10:00-11:00 am                  Investigational Device Exemption (IDE) Program
  •  11:00-12:00 noon              510(k) Program
  •  12:00-1:00 pm                    De Novo
  • 2:00-3:00 pm                      Corrective and Preventive Actions (CAPA)
  • 3:00-4:00 pm                      Electronic Medical Device Reporting (eMDR)
See detailed schedule with presenters below

How to Join the Workshop: All participants will attend via webinar

Detailed Program Schedule:
Expert Panel
10 am - 11 am
IDE Program
Soma Kalb, ODE
Soma Kalb, ODE
Elizabeth Hillebrenner, OIR
11 am - 12 noon
510(k) Program
Kim Piermatteo, OCE/DICE
Marjorie Shulman, ODE
Fatemeh Razjouyan, OIR
12 noon - 1 pm
De Novo
Elias Mallis, OCE/DICE
Joni Foy, ODE
Scott McFarland, OIR
1 pm - 2 pm
Lunch Break
2 pm - 3 pm
Corrective and Preventive Actions
Joseph Tartal, OCE/DICE
Eric Horowitz, OC
Tonya Wilbon, OIR
3 pm - 4 pm
Medical Device Reporting and eMDR
Andrew Xiao, OCE/DICE
Sharon Kapsch, OSB
Marc Wilson, OSB

CDRH’s Industry Education Improvements - Where to find regulatory information
FDA/CDRH is committed to improving transparency and providing comprehensive industry education to promote understanding of the regulations, guidance documents and policies for medical devices. 

The CDRH Industry Basics Workshop is just one way we are working to meet your educational needs.  Other improvements we’ve made to further industry education include:
  • Hosting live regulatory webinars to provide clarification for CDRH Guidance Documents as they are released. These webinars feature a presentation (posted to CDRH Learn for later reference), and live Question and Answer session; and
  • Creating new content for the CDRH Learn and Device Advice websites 

Please note: the November 4, 2014, CDRH Industry Basics Workshop is not intended to provide submission-specific feedback, so please limit your questions to broad policy questions about the program topics. Submission-specific questions will be referred to the appropriate CDRH program Office for response.

We look forward to your participation on Tuesday, November 4!

For questions about this event, please contact or call 1-800-638-2041.

For further information about CDRH Industry Educational Resources, please visit the DICE Home Page at:

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