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  5. Public Meeting - Food and Drug Administration’s Communications About the Safety of Medical Devices - 04/01/2020 - 04/01/2020
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Meeting

Event Title
Public Meeting - Food and Drug Administration’s Communications About the Safety of Medical Devices
April 1, 2020


Date:
April 1, 2020
Time:
8:30 AM - 4:30 PM ET
Location:
Event Location
White Oak Campus: The Great Room
Conference Center

10903 New Hampshire Ave
Building 31, Room 1503
Silver Spring, MD 20993
United States


The U.S. Food and Drug Administration (FDA) is announcing the following public meeting entitled “Food and Drug Administration’s Communications About the Safety of Medical Devices.”  The purpose of the meeting is to discuss the development, content and format of FDA safety communications about medical devices. It is not intended to inform the criteria for when the FDA would issue a communication. The goal of this public meeting is to share the FDA’s current practices about medical device safety communications, and to hear from our stakeholders (including patients and caregivers, healthcare providers, regulated industry, and media) about how we can improve our safety communications to assure they receive the information they need in a timely, clear, and consistent manner. 

During the meeting, we will discuss specific topics outlined in the Preliminary Agenda below.

DATE, TIME AND LOCATION

This public meeting will be held on April 1, 2020 from 8:30 a.m. to 4:30 p.m. (EST) at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Building 31, Room 1053 (the Great Room)
Silver Spring, MD, 20993

Please visit the following website for FDA Campus Information, (e.g., local airports, directions, local hotels, etc.)
https://www.fda.gov/about-fda/white-oak-campus-information/public-meetings-fda-white-oak-campus

WEBCAST

The public meeting will be webcasted live and the link will be provided in your confirmation email if you registered to view the webcast.  The link for archived webcast will be posted to the webpage for viewing after the meeting.

PRELIMINARY AGENDA

The following public meeting agenda is preliminary and subject to change.  More information will be made available as presenters are confirmed.

Time

Subject

8:30 a.m. Welcome & FDA Opening Remarks
8:45 a.m. FDA Presentation:  When, why, and how the FDA communicates safety information about medical devices
9:15 a.m. Public Session 1: Clarifying Questions for FDA
9:30 a.m. Moderated Panel Discussion with Patients/Caregivers, Healthcare Providers, Regulated Industry, and Media
  • How do you receive information from the FDA?
  • How do you prefer to receive information about medical devices?
10:00 a.m. Public Session 2: Questions/Comments about previous discussion
10:15 a.m. Break
10:30 a.m. Moderated Panel Discussion with Patients/Caregivers, Healthcare Providers, Regulated Industry, and Media
  • Is information the FDA provides about medical devices “understandable”?
  • Does the FDA deliver the “right” information about medical devices?
    • Is the information actionable?
    • What is and is not useful?
11:30 a.m. Public Session 3: Questions/Comments about previous discussion
12:00 p.m. Lunch
1:00 p.m. Moderated Panel Discussion with Patients/Caregivers, Healthcare Providers, Regulated Industry, and Media
  • What challenges do you face with the FDA’s communications about medical devices?
  • What are your recommendations for improvement
2:00 p.m. Public Session 4: Questions/Comments about previous discussion
2:45 p.m. Break
3:00 p.m. Moderated Panel Discussion with Patients/Caregivers, Healthcare Providers, Regulated Industry, and Media
  • With whom should the FDA engage before communicating publicly?
  • Under what circumstances should the FDA engage stakeholders when communicating publicly?
  • At what point(s) should the FDA engage stakeholders when communicating publicly?
4:00 p.m. Public Session 5: Questions/Comments about previous discussion
4:30 p.m. FDA Closing Remarks and Adjourn

REGISTRATION

If you wish to attend this public meeting, you must register by 4:00 p.m. on March 18, 2020.  There is no fee to register for the meeting and registration will be on a first-come, first-served basis.  Early registration is recommended because seating is limited. If time and space permit, onsite registration the day of the public meeting will be provided beginning at 7:00 a.m.  We will update this website if registration closes before the day of the public meeting.

 
Attendance In-Person
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REQUESTS FOR ORAL PRESENTATIONS:

This public meeting includes public comment sessions and topic-focused sessions. During online registration you may indicate if you wish to present during a public comment session and which specific session or topic(s) you wish to address.  We will do our best to accommodate requests to make public comments.  Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the focused sessions.  Following the close of registration, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will notify participants by March 26, 2020.  All requests to make oral presentations must be received by the close of registration on March 18, 2020 by 4:00 p.m.  No commercial or promotional material will be permitted to be presented or distributed at the meeting.

Registrants will receive confirmation when requests for participation have been accepted. Your request to speak during the open public comment session does not allow time for slides or videos, it is only an oral comment, in-person.

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Peggy Roney, Office of Communication and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5671, Peggy.Roney@fda.hhs.gov, no later than March 4, 2020.

COMMENTS

Please submit your comments about the meeting to https://www.regulations.gov/, Docket No. FDA-2020-N-0096 by June 1, 2020. 

Please refer to the Instructions for submitting comments to the docket to ensure that your feedback is taken into consideration.

The meeting transcript will be posted in the Docket as soon as it is available, and accessible at https://www.regulations.gov

CONTACT

For questions regarding meeting content please contact:

Jodi Duckhorn
Office of Communication and Education
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
Bldg. 32, Rm. 5214
Silver Spring, MD 20993
DeviceSafetyCommsPublicMeeting@fda.hhs.gov