- November 17, 2020
1:00 PM - 4:30 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 public meeting, we will discuss the specific topics outlined in the Agenda below. An introductory video with background information on the FDA's current practices for medical device safety communications is now available. We recommend watching the video before participating in the virtual public meeting.
On this page
- Date and Time
- Webcast Meeting Link
- Request for Oral Presentations
This virtual public meeting will be webcast on November 17, 2020 from 1 p.m. to 4:30 p.m. EST.
The webcast link is:
Internet Explorer and Firefox are the preferred web browsers to view this webcast.
|Before the Meeting||Reminder: Watch the Pre-Meeting Presentation|
|1:00 p.m.||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 with Patients/Caregivers, Healthcare Providers, Regulated Industry, and Media
|2:05 p.m.||Public Session 1: Questions and Comments about panel discussion 1|
|2:15 p.m.||Moderated Panel Discussion 2 with Patients/Caregivers, Healthcare Providers, Regulated Industry, and Media
|2:50 p.m.||Public Session 2: Questions and Comments about panel discussion 2|
|3:00 p.m.||Moderated Panel Discussion 3 with Patients/Caregivers, Healthcare Providers, Regulated Industry, and Media
|3:35 p.m.||Public Session 3: Questions and Comments about panel discussion 3|
|3:45 p.m.||Moderated Panel Discussion 4 with Patients/Caregivers, Healthcare Providers, Regulated Industry, and Media
|4:20 p.m.||Public Session 4: Questions and Comments about panel discussion 4|
|4:30 p.m.||FDA Closing Remarks and Adjourn|
Registration is closed as of November 3, 2020.
Registrants will receive confirmation when requests for participation have been accepted.
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.
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.
For questions regarding meeting content please contact:
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
|Instructions for Submitting Comments - FDA's Communications About the Safety of Medical Devices||pdf (142.66 KB)|