Meeting

Event Title

Virtual Public Meeting - FDA's Communications About the Safety of Medical Devices

November 17, 2020

Date:: November 17, 2020
Time:: 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.

Pre-Meeting Presentation

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.

DATE, TIME and LOCATION

This virtual public meeting will be webcast on November 17, 2020 from 1 p.m. to 4:30 p.m. EST.

WEBCAST MEETING LINK

The webcast link is:
http://fda.yorkcast.com/webcast/Play/ae1f5c351a3e4bcf9eabc7019e24b0381d

Internet Explorer and Firefox are the preferred web browsers to view this webcast.

AGENDA

Transcript

Time	Subject
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 *How do you learn about any concerns the FDA may have regarding safety Issues with your device?* Information from the FDA about the safety of medical devices? 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 expect a follow-up communication from the FDA about the safety of a medical device? How would you want to be informed that an issue is resolved? For how long should this type of information be available on the FDA’s website?
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 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? Do we need to describe what a device is or does when communicating about its safety? Do different stakeholder groups or intended audiences need different amounts or kinds of information to adequately understand the FDA’s communication about the safety of a medical device? Is it helpful to include data in safety communications, or could we provide a link to more information? If the FDA could not provide any recommended actions, would you want us to communicate about the device’s safety issue? When the FDA issues an update to a communication about the safety of a medical device, is the reason for the update clear? Describe a classification system you think would be most helpful in understanding the severity of a safety issue.
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 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?
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 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?
4:20 p.m.	Public Session 4: Questions and Comments about panel discussion 4
4:30 p.m.	FDA Closing Remarks and Adjourn

REGISTRATION

Registration is closed as of November 3, 2020.

Registrants will receive confirmation when requests for participation have been accepted.

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, [email protected], 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
[email protected]