Medical Devices

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

The purpose of the workshop is to discuss the growing need for medical device labeling to be delivered in a clear, concise, and readily accessible format so that patients, caregivers, and healthcare providers may access and utilize device labeling as efficiently and effectively as possible. This public workshop aims to engage stakeholders in active discussion with FDA and to encourage public comments regarding standard content and format for medical device labeling and the use of a repository containing medical device labeling.


Date, Time and Location

This workshop was 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

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Agenda

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.

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Webcast Archive

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More Information

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Contact Us

For questions regarding workshop content please contact:

Mary Weick-Brady, MSN, RN,
Center for Devices and Radiological Health
Food and Drug Administration
WO66 Room 5426
Phone:301-796-6089
FAX: 301-847-8510
email: Mary.Brady@fda.hhs.gov.

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Page Last Updated: 07/10/2014
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