The purpose of the public workshop is to solicit public feedback on select actions outlined in the Center for Devices and Radiological Health’s (CDRH) "Medical Device Innovation Initiative" (report). FDA is seeking input on a number of identified challenges associated with incentivizing innovation, and the proposed solutions. In addition, the agency requests comments on the Innovation Pathway proposed under the initiative.

This meeting will be held March 15, 2011, 8:00 am - 5:30 pm at the following location:

Food and Drug Administration White Oak Campus

10903 New Hampshire Avenue

Bldg. 31, Room 1503 (Salons B & C)

Silver Spring, MD 20993

The meeting will be available via webcast.

8:00 - 8:05 Welcome and Opening Remarks

Jeff Shuren, M.D., J.D., Director, CDRH

8:05 - 8:10 Structure of the Day and Logistics

Jonathan Sackner-Bernstein, M.D., Associate Center Director, Technology and Innovation, CDRH

8:10 - 8:30 Introduction: CDRH’s Medical Device Innovation Initiative
8:30 - 9:00 The Innovation Pathway
9:00 - 10:30 Open Public Session 1*

Registered Speakers

10:30 - 11:00 Horizon Scanning
11:00 - 12:00 Open Public Session 2*

Registered Speakers

12:00 - 1:15 Lunch (on own)
1:15 - 1:20 Call to Order
1:20 - 2:00 Clinical Test Center Certification
2:00 - 3:00 Open Public Session 3*

Registered Speakers

3:00 - 3:15 Break
3:15 - 3:45 Publicly-Available Core Curriculum for Medical Device Development
3:45 - 4:15 Regulatory Science
4:15 - 5:15 Open Public Session 4*

Registered Speakers

5:15 - 5:30 Closing Remarks and Adjournment

*Note: Times for Open Public Sessions may be reallocated depending on the number of Registered Speakers per session.

If you wish to attend this Workshop, you must register by close of business on March 4, 2011.

There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.

If you need special accommodations due to a disability, please contact Susan Monahan at 301-796-5661, at at least 7 days in advance of the meeting.

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For information regarding logistics, registration and special accommodations, contact:

Susan Monahan

Office of Communication, Education, and Radiation Programs

Center for Devices and Radiological Health

Food and Drug Administration

10903 New Hampshire Avenue, Bldg. 66

Silver Spring, MD 20993

phone: 301-796-5661


For information regarding the program, contact:

Jonathan Sackner-Bernstein, M.D.

Center for Devices and Radiological Health

Food and Drug Administration

phone: 301-796-6313