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  5. Virtual Public Meeting - FDA's Communications About the Safety of Medical Devices - 11/17/2020 - 11/17/2020
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Meeting

Event Title
Virtual Public Meeting - FDA's Communications About the Safety of Medical Devices
November 17, 2020

Rescheduled
Date:
November 17, 2020
Time:
1:00 PM - 3:30 PM ET

The U.S. Food and Drug Administration (FDA) is announcing a virtual public meeting: "FDA's Communications About the Safety of Medical Devices." The purpose of the meeting is to discuss the development, content and format of the FDA's 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 for medical device safety communications, and to hear from our stakeholders (including patients and caregivers, healthcare providers, regulated industry, and media) about ways to improve our safety communications to ensure our stakeholders receive the information they need in a timely, clear, and consistent manner.

During the meeting, we will discuss the specific topics outlined in the Preliminary Agenda below. An introductory video with background information on FDA's current practices for medical device safety communications will be available to watch online no later than October 12, 2020. Please note, this page will be updated to include a weblink to watch this video. We recommend watching this video before participating in the virtual public meeting.


DATE, TIME and LOCATION

This virtual public meeting will be webcast on November 17, 2020 from 1 p.m. to 3:30 p.m. EST.

WEBCAST MEETING LINK

The virtual public meeting will be webcast live and the link will be provided in your confirmation email. The link for the archived webcast will be posted to the meeting webpage for viewing after the meeting.

PRELIMINARY AGENDA

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

Time Subject
Before the Meeting Reminder: Watch the Pre-Meeting Presentation - will be available to watch online no later than October 12, 2020
1:00 p.m. Welcome and FDA Opening Remarks by Jeff Shuren, Director, Center for Devices and Radiological Health
1:10 p.m. Panel Introductions
1:30 p.m. Moderated Panel Discussion 1
  • How do you receive information from the FDA about the safety of medical devices? 
    • Specifically (email, phone, newsletters)
  • How do you prefer to receive information about the safety of medical devices?
    • Where else can you go for information about the safety of medical devices?
    • How often do you want to receive information from the FDA about the safety of a medical device?
    • When do you expect a follow-up communication from the FDA about the safety of a medical device?
1:50 p.m. Public Session 1: Questions and Comments about panel discussion 1
2:00 p.m. Moderated Panel Discussion 2
  • Is information the FDA provides about the safety of medical devices "understandable"?
  • Does the FDA deliver the "right" information about the safety of medical devices?
    • Is the main message clear?
    • Is the information actionable?
    • What is and is not useful?
    • How much detail should we include in our materials?
    • Do we need to describe what a device is or does when communicating about its safety?
    • Do patients need more information to absorb the message?
    • Is it helpful to include data in safety communications, or could we provide a link to more information?
2:20 p.m. Public Session 2: Questions and Comments about panel discussion 2
2:30 p.m. Moderated Panel Discussion 3
  • What challenges do you face with the FDA's communications about the safety of medical devices?
    • Accessibility & 508 compliance
    • Rural & access to healthcare providers
    • Internet access
    • Language & translational services
    • Comprehension
  • What are your recommendations to improve the FDA's communications about the safety of medical devices?
2:50 p.m. Public Session 3: Questions and Comments about panel discussion 3
3:00 p.m. Moderated Panel Discussion 4
  • With whom should the FDA engage before communicating publicly about the safety of medical devices?
  • Under what circumstances should the FDA engage stakeholders when communicating publicly about the safety of medical devices?
  • At what point(s) should the FDA engage stakeholders when communicating publicly about the safety of medical devices?
3:20 p.m. Public Session 4: Questions and Comments about panel discussion 4
3:30 p.m. FDA Closing Remarks and Adjourn

REGISTRATION

If you wish to attend this virtual public meeting, you must register by 4:00 p.m. on November 3, 2020. There is no fee to register for the meeting and registration will be on a first-come, first-served basis.

No dashes or spaces in phone numbers please.
Do you wish to make a presentation during the open public comment session?
Yes No
:
 

Registrants will receive confirmation when requests for participation have been accepted. We will update this website if registration closes before the public meeting.

REQUESTS FOR ORAL PRESENTATIONS

This virtual 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 or participate in a specific session, and which 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 November 10, 2020. All requests to make oral presentations must be received by the close of registration on November 3, 2020 by 4:00 p.m. No commercial or promotional material will be permitted to be presented or distributed at the meeting.

Your request to speak during the open public comment session does not allow time for slides or videos. It is only for real-time, live, oral comment.

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 November 1, 2020.

COMMENTS

Please submit your comments about the meeting to https://www.regulations.gov/docket?D=FDA-2020-N-0096, Docket No. FDA-2020-N-0096 by January 19, 2021.

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/docket?D=FDA-2020-N-0096.

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


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