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FDA To Host Public Meeting on Safety Communications about Medical Devices

FDA To Host Public Meeting on Safety Communications about Medical Devices

The FDA has announced that it will be hosting an open meeting to address the agency’s safety communications on medical devices to take place on November 17, 2020 at 1:00 PM – 3:30 PM ET. The objective of the meeting is to share with the public the current practices the FDA has in place to communicate the safety of medical devices and receive input and feedback from the public about ways to improve the existing format. The goal is to make sure the FDA’s communication on safety is clear and is timely distributed among patients and caregivers, healthcare providers, regulated industry, and the media. Upon registration, attendees will be able to submit requests to make oral presentations at the meeting on related topics.

The FDA will issue a pre-meeting video with the FDA’s current procedures for safety communications for medical devices. Attendees are encouraged to watch the video before attending the session in November.

Some key topics in the FDA’s meeting agenda include:

  • How do you receive information from the FDA about the safety of medical devices?
  • How do you prefer to receive information about the safety of medical devices?
  • 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?
  • What challenges do you face with the FDA’s communications about the safety of medical devices?
  • What are your recommendations to improve the FDA’s communications about the safety of medical devices?
  • 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?

For more information, visit the FDA’s registration page.

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