FDA Public Workshop – Accessible Medical Device Labeling in a Standard Content and Format, April 29-30, 2013

This workshop will be held April 29, 2013 from 8:00 am to 5:00 pm and April 30, 2013, from 8:00 am to 4:00 pm EST at the following location:

FDA White Oak Campus

10903 New Hampshire Avenue,

Building 31, Conference Center (Great Room 1503A)

Silver Spring, MD 20993


Day 1

Morning introductions and expectations followed by main address

Summary of surveys from health care professionals and National Family Caregivers Association on
medical device labeling

CRADA with Kwikpoint and the development of a visual language

CDER-measures of success with electronic submission of drug labeling

Development of a standard content and format

The use of a shortened or quick guide version of labeling

Day 2

Clinical perspectives panel to discuss medical device labeling. Including: ER physician, staff nurse,
caregiver, patient, home health professional

Regulatory perspectives panel. Including: analyst, pre-market staff, industry representative

Results from a pilot conducted for the electronic submission of labeling

Medical device labeling repository and ways of accessing labeling.

Registration to Attend the Workshop:

If you wish to attend this Workshop, you must register by close of business on April 5, 2013. If you wish to view this Workshop by Webcast you must also register by close of business on April 5, 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.

Public Comment

If you wish to make an oral presentation during any of the open comment sessions at the meeting you must indicate this at the time of registration. FDA requests that presentations focus on the areas defined in the Federal Register Notice. You should also identify which discussion topic you wish to address in your presentation and you must submit a brief statement that describes your experience and/or expertise relevant to your proposed presentation. In order to keep each open session focused on the discussion topic at hand, each oral presentation should address only one discussion topic. FDA will do its best to accommodate requests to speak. FDA will determine the amount of time allotted to
each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by April 12, 2013. All requests to make oral presentations must be received by the close of registration on April 5, 2013, at 5:00 p.m.. If selected for presentation, any presentation materials must be emailed to the Mary Weick-Brady no later than April 19, 2013.

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Joyce Raines, 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, 301-796-5709, FAX: 301-847-8142, email: joyce.raines@fda.hhs.gov.