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).
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
Webinar Link includes video and audio: http://fda.yorkcast.com/
webcast/play/ c369da3174e945db99747267beeb2a 551d
Detailed Program Schedule:
10 am - 11 am
Soma Kalb, ODE
Soma Kalb, ODE
Elizabeth Hillebrenner, OIR
11 am - 12 noon
Kim Piermatteo, OCE/DICE
Marjorie Shulman, ODE
Fatemeh Razjouyan, OIR
12 noon - 1 pm
Elias Mallis, OCE/DICE
Joni Foy, ODE
Scott McFarland, OIR
1 pm - 2 pm
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 DICE@fda.hhs.gov or call 1-800-638-2041.
For further information about CDRH Industry Educational Resources, please visit the DICE Home Page at:http://www.fda.gov/
MedicalDevices/ DeviceRegulationandGuidance/ ContactUs-- DivisionofIndustryandConsumerE ducation/default.htm