The Food and Drug Administration (FDA) is announcing the following public workshop entitled "The Patient Preference Initiative: Incorporating Patient Preference Information into the Medical Device Regulatory Processes”.

The purpose of this workshop is to discuss ways to incorporate patient preferences on the benefit-risk trade-offs of medical devices into the full spectrum of the Center for Devices and Radiological Heath (CDRH) regulatory decision making. It also aims to advance the science of measuring treatment preferences of patients, caregivers, and health care providers.



Date, Time and Location:

This meeting will be held September 18 and 19, 2013, beginning at 8:00 a.m. at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503A (Section A of the Great Room)
Silver Spring, MD, 20993


This public workshop will also be Webcast. Persons interested in viewing the Webcast must register online by 4 p.m. on September 11, 2013. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and will be sent connection access information after September 12, 2013. If you have never attended a Connect Pro event, test your connection at To get a quick overview of the Connect Pro program, visit:

Preliminary Agenda

The agenda will be announced.

Registration to Attend the Workshop:

If you wish to attend this Workshop, you must register by 4:00 p.m. on September 11, 2013.  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.

Attendance In-Person
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Public Comment

In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public workshop topics. Regardless of attendance at the meeting, interested persons may submit either written comments regarding this document to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm.1061, Rockville, MD 20852 or electronic comments to

Workshop Details

Food and Beverages will be available for purchase during the breaks.

Contact Us

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5661, FAX: 301-847-8142,

For questions regarding workshop content please contact Mimi Nguyen, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Room 5437, Silver Spring, MD 20993-0002, 301-796-4125, email:


Nada Hanafi, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 3623, Silver Spring, MD 20993-0002, 301-796-5427, email: