Medical Devices

Public Workshop - Medical Device Patient Labeling, September 29-30, 2015

The Food and Drug Administration (FDA) is announcing a public workshop entitled “Medical Device Patient Labeling”. The purpose of the public workshop was to discuss issues associated with the development and use of medical device patient labeling including content, testing, use, access, human factors, emerging media formats, and promotion and advertising. The Center for Devices and Radiological Health is seeking input about these topics from patients and advocacy groups, academic and professional organizations, industry, standards organizations, and governmental agencies.


Date, Time and Location

This 2-day workshop was held September 29-30, 2015, from 8:00 a.m. to 5:00 p.m. each day at the following location:

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

Webcast Archive

Transcripts

Presentations

Agenda

Day 1, September 29, 2015
TimeEventSpeaker
8:00-8:10WelcomeAntoinette (Tosia) Hazlett, MSN, RN
8:10-8:25Keynote Address: What is the role of Medical Device Patient Labeling?Lauren Silvis, JD
 Session 1 - Medical Device Patient Labeling Overview - CDRHModerator: Markham Luke, MD, PhD
8:25-8:35Overview of current patient labeling guidanceKristine Butler, MS
8:35–8:45Patient preference draft guidanceMichelle Tarver, MD, PhD
8:45-8:55Overview of Unique Device Identification (UDI)Linda Sigg, MS
8:55-9:05Overview of CDRH work on LabelingAntoinette (Tosia) Hazlett, MSN, RN
9:05-9:15Q&A to Panel / Audience commentsPanel
 Session 2 - Medical Device Patient Labeling  - Development and ReviewModerator: Ed Israelski, PhD
9:15-9:25Patient Labeling Development and Review- CDERLaShawn Griffiths, MHSc, RN
9:25-9:35Patient Labeling Development and Review - CDRHXin Feng, PhD / Kristine Butler, MS
9:35-9:45Human factors standards (TIR49 & HE75)Daryle Gardner-Bonneau, PhD
9:45-10:00Needs assessment in labeling developmentEvan Edwards, MS
10:00-10:20Q&A to Panel / Audience commentsPanel
10:20-10:35Break 
 Session 3 - Stakeholder Perspectives on the Use of Medical Device Patient Labeling Moderator: Toni Stifano
10:35-10:50Patient perspectiveBennet Dunlap, MSHC
10:50-11:05Patient perspectiveLori Katz
11:05-11:20Caregiver PerspectiveJohn Schall, MPP
11:20-11:35Health Care Provider PerspectiveMary Curry Narayan, MSN, RN
11:35-12:15Q&A to Panel / Audience commentsPanel
12:15-1:15Lunch 
 Session 4 - Beyond paper - New Approaches to Communicating Labeling to PatientsModerator: Patricia Patterson, CPT
1:15-1:25Special Situations - Advertising and PromotionDeborah Wolf, JD
1:25-1:40Special Situations - Advertising and PromotionRichard T. Cleland, JD
1:40-1:55Alternate media formats and methods of accessJoyce Lee, MD, MPH
1:55-2:10Visual languageRon Charnock
2:10-2:25New research on effective patient communicationMonique Mitchell Turner, PhD
2:25-2:45Q&A to Panel / Audience commentsPanel
2:45-3:00Break 
3:00-3:45User Differences: Who is your audience?  - Panel DiscussionModerator: Ruth Fischer, MS
Panel: Joyce Lee, MD,
Aaron Charles, MD, Melissa Lemke, Jonca Bull, MD
3:45-4:05Q&A to Panel / Audience commentsPanel
4:05-4:45Public CommentsModerator - Ruth Fischer, MS
4:45-5:00Summary of Day OneAntoinette (Tosia) Hazlett, MSN, RN
Day 2, September 30, 2015
TimeEventSpeaker
8:00-8:15Welcome & RecapAntoinette (Tosia) Hazlett, MSN, RN
8:15-8:55Session 5 - What are the key areas of patient Labeling?Moderator: Mary Weick-Brady
Panel: Ron Charnock, Patricia Patterson, Bennet Dunlap, Mary Curry Narayan
8:55-9:10Q&A to Panel 
9:10-9:50Session 6 - How should the information be presented?Moderator: Mary Weick-Brady
Panel: Ed Israelski, Michelle Tarver, Lori Katz, Sidney Katz, Alicia Pape, Brian Pedersen
9:50-10:05Q&A to Panel 
10:05-10:20Break 
10:20-10:40Session 7 – How can section headings and placement of key areas be most useful in patient labeling?Moderator:  Stayce Beck
Panel: Xin Feng, John Schall, Alicia Pape, Brian Pedersen
10:40-10:55Q&A to Panel / Audience comments 
10:55-11:15Session 8 – How can information about the description of the device be most useful?Moderator: JoAnn Brumbaugh Panel: Devora Gainsburg, Dave Osborn, Daryle Gardner-Bonneau
11:15-11:30Q&A to Panel / Audience comments 
11:30-11:50Session 9 – How can operating and troubleshooting information be most useful?Moderator: Daryle Gardner-Bonneau
Panel: Melissa Lemke, Devora Gainsburg, JoAnn Brumbaugh, Dave Osborn
11:50-12:05Q&A to Panel / Audience comments 
12:05-1:05Lunch 
1:05-1:45Session 10 – What information is important to include as additional information, appendices & references?Moderator: Toni Stifano
Panel: Colleen Lee, Zach Rothstein, Leah Kendall
1:45-2:00Q&A to Panel / Audience comments 
2:00-2:15Summary of Day TwoAntoinette (Tosia) Hazlett, MSN, RN
2:15-2:30Closing RemarksLauren Silvis, JD

Contact Us

For questions regarding workshop content please contact:

Antoinette (Tosia) Hazlett, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Rm 5424, Silver Spring, MD  20993-0002, 301-796-6119, email: Tosia.Hazlett@fda.hhs.gov.

Page Last Updated: 11/17/2015
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