- April 1, 2020
8:30 AM - 4:30 PM ET
The FDA, like other government agencies, is taking the necessary steps to ensure the agency is prepared to continue our vital public health mission in the event that our day-to-day operations are impacted by the COVID-19 public health emergency. Therefore, we are cancelling or postponing all non-essential meetings through the month of April. We will reassess on an ongoing basis for future months. Where possible the agency will leverage technology to host meetings allowing for remote participation.
The April 1, 2020 public meeting on "Food and Drug Administration’s Communications About the Safety of Medical Devices Public Meeting" is postponed. We are aiming to reschedule for this fall. Please follow the FDA's website for updates.
Please contact CDRHPublicMeetings@fda.hhs.gov with questions.
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.
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.
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.
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.
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 (26.10 KB)|