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Master Class Overview

Since we will be in our nation’s capital this April, OIS is teaming up with the CDRH to create a unique Master Class focusing on Pathways for Expediting Ophthalmic Device Innovation.

The OIS@ASCRS Master Class, will feature CDRH staff members discussing novel mechanisms and pathways aimed at facilitating innovation. Some of these pathways include Digital Health Functionality Initiatives to foster innovation in ophthalmic devices, a decrease in total time to decision for 510(k) submissions, and providing early evaluation of small human clinical studies to help improve development strategies for expedited accessibility of certain products intended for unmet public health needs. Additionally, we incorporate patients’ perspectives into device development and evaluation process through improved use of patient reported outcomes (PROs) and patient preference information (PPI).

The discussion will enable attendees to have suitable resources to address scientific and regulatory challenges raised by innovative devices. CDRH is committed to have a product's timely progress to market without compromising safety or effectiveness with patients as the ultimate beneficiaries.

Speakers

Director
DOED/CDRH/FDA
Acting Branch Chief
CLRD/DOED/CRDH/FDA
Associate Director
DOED/CDRH/FDA
Chief
ICIB/DOED/CDRH/FDA
Medical Physicist
DSDB/DOED/CDRH/FDA
Medical Officer
DOED/CDRH/FDA

Agenda

Friday, April 13, 2018
8:00 - 8:30 AM

Check-in & Networking Breakfast

8:30 - 8:35 AM

Welcome Remarks

8:35 - 9:05 AM

Mechanisms to Decrease Total Time to Decision (TTD) for Ophthalmic 510(k) Submissions

Presented By:
Denise Hampton, PhD
, Associate Director - DOED/CDRH/FDA

9:05 - 9:35 AM

Digital Health Functionality Initiatives to Foster Innovation in Ophthalmic Devices

Presented By:
Ron Schuchard, PhD
, Medical Physicist - DSDB/DOED/CDRH/FDA

9:35 - 10:05 AM

Patient Reported Outcomes (PROs) and Patient Preference Information (PPI)

Presented By:
Michelle Tarver, MD, PhD
, Medical Officer - DOED/CDRH/FDA

10:05 - 10:35 AM

Networking & Refreshment Break

10:35 - 11:05 AM

FDA’s Early Feasibility Study (EFS) Program

Presented By:
Angelo Green, PhD
, Acting Branch Chief - CLRD/DOED/CRDH/FDA

11:05 - 11:35 AM

Overview of Humanitarian Device Exemption (HDE) and Breakthrough Devices Program

Presented By:
Tieuvi Nguyen, PhD
, Chief - ICIB/DOED/CDRH/FDA

11:35 - 12:05 PM

Open Q&A

Participants:
Malvina Eydelman, MD
, Director - DOED/CDRH/FDA
Angelo Green, PhD, Acting Branch Chief - CLRD/DOED/CRDH/FDA
Denise Hampton, PhD, Associate Director - DOED/CDRH/FDA
Tieuvi Nguyen, PhD, Chief - ICIB/DOED/CDRH/FDA
Ron Schuchard, PhD, Medical Physicist - DSDB/DOED/CDRH/FDA
Michelle Tarver, MD, PhD, Medical Officer - DOED/CDRH/FDA

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- Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
- Center for Devices and Radiological Health (CDRH)
- Diagnostic and Surgical Devices Branch (DSDB)
- Contact Lens and Retinal Devices Branch (CLRD)
- Intraocular and Corneal Implants Branch (ICIB)

DOWNLOAD THE FDA REFERENCE LIST

Venue

Renaissance Washington, DC Downtown Hotel

999 Ninth Street NW Washington

District of Columbia 20001

(202) 898-9000

the renaissance hotel washington dc

All Federal Employees are Free to Enter
OIS@ASCRS Master Class 2018, but
Must be Registered.

Please take a moment to fill out the request form. Following the completion of this form, you will be contacted by an OIS Staff Member within 2 business days.