sábado, 19 de septiembre de 2020

Virtual Public Meeting – Communications About the Safety of Medical Devices



Virtual Public Meeting – Communications About the Safety of Medical Devices

On September 17, 2020, the U.S. Food and Drug Administration (FDA) announced that the public meeting, FDA’s Communications About the Safety of Medical Devices, will be held virtually on November 17, 2020. This meeting was rescheduled from the original date of April 1, 2020.
 Mic
During this meeting, we will:
  • Share the FDA’s current practices for medical device safety communications, including development, content, and format of safety communications
  • Hear from you about ways to improve our safety communications to ensure our stakeholders—including patients, caregivers, health care providers, regulated industry, and the media— receive the information they need in a timely, clear, and consistent manner.

Important Deadlines
  • By November 3, 2020: Register to attend the meeting by 4:00 p.m.
    • If you previously registered to attend the meeting on April 1, then you will need to register again to attend this virtual meeting on November 17.
  • By November 3, 2020Request to make oral presentations by 4:00 p.m.
    • If you previously requested to make oral presentations at the meeting on April 1, then you will need to request again to present at this virtual meeting on November 17.
  • By January 19, 2021Submit written comments to the docket (FDA-2020-N-0096)
    • If you previously submitted written comments, then you will not need to submit comments again.

Medical Device Safety Action Plan
Ensuring that the FDA is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices is an important milestone in the FDA's continued work on the Medical Device Safety Action Plan. Robust oversight of safety also requires timely public communication about safety issues and effective interventions to address concerns.
In today’s announcement of the virtual public meeting on communications about the safety of medical devices, the FDA is taking another step towards the goals of the Medical Device Safety Action Plan, which will help us to improve the safety, health, and quality of life of patients and enable decision-making based on the best available evidence about medical devices.

Questions?
If you have questions about the public meeting, email DeviceSafetyCommsPublicMeeting@fda.hhs.gov.

No hay comentarios: